A higher dose version of naloxone, the nasal spray used to reverse opioid-induced overdoses, did not lead to more saved lives, according to a new study published earlier this month.

The findings, published by the Centers for Disease Control and Prevention, indicated that “no significant differences were found in the survival of aided persons” in the new eight-milligram naloxone.

According to the study, there were likewise no significant differences in “the number of doses administered by law enforcement by formulation, suggesting that, in this field test, the increased dosage did not provide added benefit, even in light of the increased prevalence of synthetic opioids, including fentanyl, in the drug supply.”

“Other studies have also found that [the] number of naloxone doses administered in response to overdose has not changed over time, even with 4-mg and other lower-potency formulations,” the study said. 

“In this study, persons who received the 8-mg product were more than twice as likely to experience postnaloxone opioid withdrawal signs and symptoms including vomiting, compared with those who received the 4-mg intranasal naloxone product. When vomiting was analyzed as an isolated sign, no significant differences between formulations were found. However, the high prevalence of vomiting as an isolated sign in both groups is concerning because of the risk of aspiration in sedated persons.”

Dr. Michael Dailey, one of the authors of the study, told the Associated Press that what “was really remarkable was the survival was the same, but the amount of withdrawal symptoms was significantly larger in the people that got the 8-milligram dose.”

The study was conducted between March 2022–August 2023, when the  “New York State Department of Health (NYSDOH) supplied some New York State Police (NYSP) troops with 8-mg intranasal naloxone” and “other troops continued to receive 4-mg intranasal naloxone to treat suspected opioid overdose,” the authors explained in the study’s abstract. 

“NYSP submitted detailed reports to NYSDOH when naloxone was administered. No significant differences were observed in survival, mean number of naloxone doses administered, prevalence of most postnaloxone signs and symptoms, postnaloxone anger or combativeness, or hospital transport refusal among 4-mg and 8-mg intranasal naloxone recipients; however, persons who received the 8-mg intranasal naloxone product had 2.51 times the risk for opioid withdrawal signs and symptoms, including vomiting, than did those who received the 4-mg intranasal naloxone product (95% CI = 1.51–4.18),” they explained. 

“This initial study suggests no benefits to law enforcement administration of higher-dose naloxone were identified; more research is needed to guide public health agencies in considering whether 8-mg intranasal naloxone confers additional benefits for community organizations.”

The authors noted that although the 8-mg naloxone was first approved by the Food and Drug Administration for emergency use in 2021, “no real-world data on use of the 8-mg product are available.”

“Harm reduction advocates and medical professionals have noted potential harms of higher-dose naloxone, including severe withdrawal signs and symptoms, which can result in refusal of medical care, rapid reuse of opioids, reluctance to use naloxone if witnessing an overdose, and respiratory complications, including pulmonary edema and consequences of aspiration of vomitus,” they said. 

“To evaluate this potential risk, in 2022, NYSDOH partnered with NYSP to field test 8-mg intranasal naloxone use by some NYSP troops. The aims of the study were to conduct real-world comparisons of survival, the average number of doses administered, presence of postnaloxone signs and symptoms, and hospital transport refusal among persons receiving the 8-mg or the 4-mg intranasal naloxone products.”

According to the Associated Press, “Dailey said the study did not lead him to endorse one product over another,” but he added that it is “important for us to recognize that the potential for increased side effects is real.”

The authors of the study also pointed out that their research was “subject to at least four limitations.” 

“First, responding law enforcement personnel are not medical providers, and inconsistencies in their classification of postnaloxone symptoms or behaviors might have occurred. However, NYSP personnel have been reporting using a similar form for several years and are experienced in assessing symptoms and behaviors. Second, the number of 8-mg intranasal naloxone administration reports included was limited because only three of 11 NYSP troops received this formulation. With an increased sample size, additional differences in outcomes between groups might have been observed,” they explained. “Third, no information could be compared about differences between groups on the type or dose of substance used before suspected overdose, vital signs, or demographics. Finally, because the data were gathered from New York State only, the opioid potency might not reflect that in other areas.”

Although the “study suggests that there are no benefits to law enforcement administration of higher-dose naloxone,” the authors said that “additional data are needed to guide public health agencies in considering whether the 8-mg intranasal naloxone product provides benefits compared with the usual 4-mg intranasal naloxone product among community organizations, including law enforcement, given the lack of difference in survival rates or number of naloxone doses administered and the increased prevalence of opioid withdrawal signs and symptoms, including vomiting, in 8-mg recipients, when compared with recipients of 4-mg intranasal naloxone.”

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As per a new law, the Department of Defense will begin tracking overdoses within the United States military in 2024 and begin to provide naloxone to service members beginning in 2025. 

Military overdose deaths have historically not been systematically tracked until the release of a report by Rolling Stone in 2022 detailing the steep rise in overdose deaths at Fort Bragg, which has since been renamed to Fort Liberty. The report detailed the shocking increase in deaths from fentanyl, counterfeit prescription pills laced with fentanyl and deaths in otherwise healthy young men from causes typically sustained from long-term drug use that were not labeled as overdoses.

In general, Rolling Stone described shoddy record-keeping and experienced a general lack of transparency from the brass at Fort Liberty regarding drug use, drug-related crimes or overdose by military members. Of the 109 deaths that occurred at Fort Liberty between 2020 and 2021, at least 14 soldiers died directly from overdose, though that number is likely higher if you count deaths from drug-related causes, 21 by Rolling Stone’s count, making accidental overdose the leading cause of death at Fort Liberty behind suicide which claimed the lives of 41 soldiers in the same time period. 

After the Rolling Stone report, pressure built on Congress to do something about the issue and Senator Edward Markey (D-Mass.) along with other congressmen began to push the Pentagon for increased transparency. This request led to an admission by the Pentagon that fentanyl-related deaths roughly doubled among military members between 2017 and 2021, much like the rest of the country experienced. According to a Military.com report, 330 service members died from drug overdose between 2017 and 2022, and 15,000 soldiers experienced non-fatal overdoses in the same time frame. 

“Real security means guaranteeing that members of the military and their families can get resources and life-saving treatment necessary to stop the overdose crisis in its tracks,” Senator Markey said in a statement to Military.com.

The law requiring overdose tracking and NARCAN distribution was signed by President Biden in December of 2022 and goes into effect in 2024. According to Military.com, the Department of Defense will be required to submit an annual report on overdose deaths, overdose locations, demographics, whether the service member had previously sought mental health treatment, or if they’d previously been prescribed opioids, benzodiazepines or stimulants.

“It’s really just smart public health,” said Professor Alex Bennett to Military.com. Bennett serves as the director of New York University’s Opioid Overdose Prevention Program. “There’s really a lot of drug naivete amongst military personnel,” Bennett said.

Part of the issue, as is the same with the civilian population, is that fentanyl is often used to make “pressed pills” or fake prescription pills designed to look like pharmaceutical painkillers or benzodiazepines which are often poorly dosed, causing people to unwittingly ingest a lethal dose of fentanyl. The Drug Enforcement Administration has estimated that about 70% of fake prescription pills contain a potentially lethal dose of fentanyl. 

“We’ve been working with a lot of veterans who use substances while they’re in the military. Transparency with data tracking like the kind the military is set to begin doing is a step in the right direction,” Bennett said. “Closing your eyes to drug problems doesn’t solve anything,” Bennett said. “It just makes things worse.”

Carole De Nola, whose 23-year-old child died of an overdose while stationed at Fort Liberty, told Military.com that drug education is especially needed among military members as the new law does not require the military to educate service members on the dangers of fentanyl.

“We should be dealing with this before a service member’s about to overdose,” De Nola said. 

It was not immediately clear how the military would be distributing naloxone, commonly known as NARCAN, which is a life-saving medication that can halt an opioid overdose in its tracks. Many NARCAN distribution programs have been established at the level of local cities and townships but nothing has been established federally, or by military leadership until the new law was passed. The new law requires that naloxone be made available to all troops by the year 2025. The law also requires all the naloxone distributed by tracked, which could discourage some military members from seeking it out. 

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The White House is urging American public schools to carry Naloxone, commonly known as NARCAN, to help combat sky-high overdose rates from fentanyl.

A letter was sent regarding fentanyl awareness from United States Secretary of Education, Miguel Cardona and the Director of the Office of National Drug Control Policy, Rahul Gupta to all U.S. schools. The letter called on school administrators and educators to take conscious efforts towards harm reduction in the face of a drug they said was having a “disproportionate impact on our children.”

The letter emphasized how effective naloxone, which is an opioid antagonist medication, can be. Naloxone can stop an opiate overdose in its tracks if administered quickly enough and as the letter also mentioned, it’s an incredibly safe medication to use.

“Studies show that naloxone access can reduce overdose death rates, that its availability does not lead to increases in youth drug use, and that it causes no harm if used on a person who is not overdosing on opioids,” the letter said. “It is important to note that individuals should not be afraid to administer naloxone, as most states have Good Samaritan Laws protecting bystanders who aid at the scene of an overdose. Our schools are on the frontlines of this epidemic, but our teachers and students can be equipped with tools to save lives.”

The Biden administration has made previous efforts to combat an issue that has managed to affect almost every community in the country, including making naloxone an over-the-counter medication. This latest development, however, marks the most concrete acknowledgement by the Biden administration that the fentanyl problem is affecting America’s children.

“Overdose deaths among adolescents doubled from 2019 to 2020 and continue to rise, even though youth rates of drug use have remained stagnant. That’s because a teenager today can log onto social media with a smartphone and buy what they think is an opioid pain medicine or a prescription stimulant to help them study—and instead die from one pill that actually has fentanyl in it. Just one pill,” the letter said. “And data show that two-thirds of adolescent drug poisoning deaths occurred with a potential bystander nearby, but naloxone was often not administered.”

Naloxone has proven to be, in the most blunt possible terms, the only tool which has managed to prevent any tangible number of deaths from fentanyl, which is hundreds if not thousands of times stronger gram for gram than almost any other opiate available legally or illegally and has killed hundreds of thousands of Americans since emerging onto the scene. Naloxone is administered via an easy-to-use nasal spray which will not harm anyone, even if they don’t have opiates in their system, according to the FDA. 

For a long time naloxone was somewhat hard to find, only available through a prescription and very expensive especially for anyone in active drug addiction. Previously, doses could cost upwards of $100 but today, single doses currently run about $45 through most pharmacies and some overdoses require more than one dose of naloxone to reverse it. The letter from the Biden administration emphasized how critical it is that our nation’s teachers and school administrators understand this life-saving medication and stay prepared to use it.

“Our schools are on the frontlines of this epidemic, but our teachers and students can be equipped with tools to save lives,” the letter said. “There is no time to waste when responding to an overdose, and it is critical that youth and school personnel can access naloxone on school grounds during and after school.”

There are now several programs which will provide a certain number of free doses of naloxone to eligible participants. A cursory Google search of “free naloxone + your local township, county or state” will, in many places, provide options for free naloxone for at-risk people if not everybody. If your area does not have a free program, you can visit Next Distro which sends free doses to people who cannot otherwise access it.

I must break from journalistic candor for a moment to urge everybody reading this, even people who do not use drugs, even people who do not believe they know any addicts (though I can assure you that you do), please carry naloxone with you whenever possible. Opiate addiction affects people of every shape and size, every cultural and economic background. It’s affecting children, it’s affecting everybody and carrying naloxone unequivocally saves lives. Don’t take my word for it either, take the president’s.

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Americans say that cannabis is much less dangerous than opioids, alcohol, and cigarettes, according to a new survey conducted by the American Psychiatric Association (APA) and Morning Consult last week. The survey results come from interviews with 2,201 adults conducted between April 20 and 22 of 2023, with a +/-2 percentage point margin of error, analyzing public opinion on the dangers and addictiveness of six different substances—and technology. 

Regarding cannabis, 38% said that it is “very or somewhat unsafe.” Comparatively, 84% of respondents said they regarded cigarettes as unsafe. Sixty-four percent believe alcohol to be unsafe, 66% found prescription opioids unsafe, and 75% found non-prescription opioids unsafe. Reminding us of the negative public perception of vapes, 76% responded that vapes are unsafe. While technology will lose in other categories (here’s where we unintentionally ironically tell you to keep scrolling on your screen to find out), people said that technology was safer than cannabis, with only 23% described as very or somewhat unsafe, making it the only category deemed safer than marijuana. 

The survey also analyzed the public’s perception of addiction. In that category, they perceive cannabis to be less addictive than all of the substances mentioned, in addition to technology. Sixty-four percent said that cannabis can be addictive. Eighty-seven percent say cigarettes are addictive, and 84% deem alcohol addictive. Prescribed opioids are considered 83%, a figure that drops to 74% for non-prescribed opioids. Eighty-one percent think vapes are addictive, and 75% find technology addictive. 

“It is clear that we have gotten the message through that cigarettes are dangerous and addictive,” APA President Petros Levounis said in a press release. “We can help prevent more Americans from other potentially addictive behaviors, like drinking alcohol and technology use.” “For instance, vaping is just as, if not more, addictive than cigarette smoking,” Levounis adds. 

However, even though science agrees that addiction is a medical condition (check out this study published in the Journal of Psychiatry and Neuroscience), 47% said that addiction results from “personal weakness,” which gives us insight into the stigma surrounding substance use disorders. While cannabis is generally not considered physically addictive, remember that other substances the survey covers, such as opioids, are highly addictive due to how they affect the brain, research confirms. If someone is prescribed opioids after sustaining injuries in an automobile accident, for instance, and they develop an addiction, it is scientifically proven to be due to changes in the brain rather than a lackluster set of morals. 

However, Levounis says the survey can be helpful by offering insight into how to educate the public best. “We can also make sure that people know about our current safe and effective treatments for both substance use disorders and behavioral addictions,” he says. “Addiction treatment works.”

And the numbers are higher for those with less regressive views regarding the cause of addiction. Seventy-six percent of respondents answered that addiction is a medical condition, and 93% of those polled said substance use disorders can be treated, with 76% responding that the condition is preventable. 

The survey also offers insights into the importance of increasing awareness regarding naloxone, a life-saving opioid anti-overdose drug. Only 58% said they were aware of naloxone, and only 35% said they’d know how to access it if they needed it for an overdose. Naloxone can reverse an overdose, but only if used 30 to 90 minutes after the incident is discovered. As a result, it is something everyone should have on hand rather than search for when discovering an overdose. Considering that the study found that 71% of Americans say they’d know how to help someone in their life who’s struggling with addiction, it’s clear that one of the biggest takeaways from the research is the importance of naloxone awareness. 

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The Food and Drug Administration on Monday said that it had given regulatory approval to a nasal spray that has proven effective in reversing overdoses caused by fentanyl and other opioids.

The spray, known as Opvee, is the “the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older,” the FDA said in the announcement, adding that it is also the “first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.”

The approval is yet another step by policymakers in the United States to stem the tide of a nationwide drug crisis. Earlier this month, the U.S. Centers for Disease Control and Prevention reported that overdoses from fentanyl have spiked dramatically in recent years.

In Monday’s announcement, the FDA said that drug overdose “persists as a major public health issue in the United States, with more than 103,000 reported fatal overdoses occurring in the 12-month period ending in November 2022, primarily driven by synthetic opioids like illicit fentanyl.” 

It is also part of the FDA’s “Overdose Prevention Framework,” a program launched last year “to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.” Earlier this year, the FDA approved the first overdose-reversal product that can be obtained without a prescription.

“The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” FDA Commissioner Robert M. Califf said in Monday’s announcement. 

“On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders.”

The opioid crisis in the United States has prompted lawmakers throughout the country to improve access to potentially life-saving drugs that can be used in the event of an overdose. The best-known is naloxone, which “has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers,” according to the Associated Press.

Opvee works similarly to naloxone, the AP said, and it has “achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray.”

More from the FDA:

“The approval of Opvee was supported by safety and pharmacokinetic studies, as well as a study in people who use opioids recreationally to assess how quickly the drug works. The most common adverse reactions include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose (rhinalgia), decreased appetite, skin redness (erythema) and excessive sweating (hyperhidrosis). The use of nalmefene hydrochloride in patients who are opioid-dependent may result in opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, fast heart rate (tachycardia), fever, runny nose, sneezing, goosebumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.”

In Minnesota, lawmakers are pushing to make Narcan available in schools.

“We simply cannot tolerate more needless loss of life. We have to act with urgency and we have to act now,” said Minnesota state Sen. Kelly Morrison, a Democrat, who is sponsoring the bill.

In its report released earlier this month, the CDC found that 69,943 people died of a fentanyl-induced overdose in 2021, which equals to a rate of 21.6 and is up considerably from 2016, when 18,499 died of an overdose from fentanyl at a rate of 5.7.

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The future is now: Vending machines in 2023 dispense cannabis, beer, art, cupcakes, and now the life-saving drug Narcan, as we race into an automated world.

Santa Clara University (SCU) in California announced the installation of a free on-campus vending machine that dispenses canisters of the opioid-overdose reversing medication Narcan.

“Naloxone is a miracle drug that can reverse an opioid overdose within minutes,” Santa Clara University Assistant Professor of Public Health Jamie Chang told NBC Bay Area. “To not provide this seemed really counterintuitive to a lot of public health principles.”

One of the goals is to avoid the stigma surrounding opioid overdoses, and instead see Narcan as a life-saving instant solution. The fact is that people die because friends are afraid to dial 911, or are unaware of Good Samaritan laws that protect people from trying to save a life from an overdose. But students need to have the Narcan on-hand in order to act fast in most situations.

“Our goal for this is to get naloxone out into the community because the more naloxone that people have in their hands, the more chances there are to save a life,” student Isabella Bunkers said.

The vending machine concept is likely coming to a university near you. The Mercury News reports that Stanford University plans to introduce one in a few weeks. “SCU is a party school, so drug use is something that we know happens on campus, off campus or near campus,” said Setareh Tehrani, who helped launch the project.

The idea was inspired by the death of Charlie Ternan, a former SCU student, who died of fentanyl poisoning while his friends thought he was asleep at an off-campus fraternity in 2020.

This arrives as one in five youth deaths in California are blamed on fentanyl and opioids, according to preliminary data from the California Department of Vital Statistics. Fentanyl killed a record 5,722 Californians in 2021, much more than the estimated 4,258 people who died in auto accidents in the state and more than twice the 2,548 killed in homicides.

You don’t even have to be looking for fentanyl to overdose from it: Two students at Ohio State University died from fentanyl overdoses, according to a May 5 announcement by the Columbus Police Department, and officials say the fentanyl was disguised as Adderall. 

While Narcan can cost up to $150 without insurance, most students can’t afford the cost, which is one of the core purposes of the project. Additionally, when someone is overdosing on an opioid, fumbling around for a payment method might take too long to save a life.

“The first thing is that it’s free, and it’s in a place that is widely accessible to students,” said Chang, who helped launch the campus vending machine. “(But even) regardless of whether or not students decide to take the Naloxone, we’re hoping that it at least sends the message that they need to take this seriously and that there are tools out there for them.”

Under California’s Senate Bill 367, public colleges in California, public schools are required to provide access to Narcan on campuses. Some high schools in the state are taking the initiative to provide Narcan for students.

Santa Clara County is considering installing similar vending machines on high school campuses.

“People are more aware of fentanyl. We’ve talked about it everywhere, from Greek life to club sports to varsity sports,” said Olivia Pruett, a senior who studies public health. But Narcan “is only effective if people have it when they need it. This conversation has to keep happening.”

Meanwhile, lawmakers in Minnesota are trying to pass a bill that would require schools in the state to have the opioid overdose reversal drug Narcan available in the event of an emergency situation.

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A bill proposed in Colorado would give the go-ahead to local governments to set up so-called “safe injection sites” within their jurisdictions, with advocates saying that the facilities help prevent overdoses and save lives. 

The sites, also known as “overdose prevention centers,” have been authorized in other states and cities in the United States –– but rarely without controversy. 

The legislation introduced in the Colorado House of Representatives would allow “localities to set up a site where people can use previously obtained controlled substance[s] in a monitored setting,” according to local news station Denver7.

The Associated Press reported that Democratic lawmakers there “pushed the controversial bill forward in committee Wednesday,” but while the party controls the state General Assembly, “the measure faces steep odds amid broad backlash from police, Republicans, and lingering questions about whether the sites are even legal in the United States.”

A year ago, the U.S. Department of Justice told the Associated Press that it was “evaluating” the sites and in discussion with regulators about implementing “appropriate guardrails.”

“It does not supply drugs by any means. And it also doesn’t force any local government in a city to establish one of these sites in their communities,” said Colorado state House Rep. Jenny Willford, a Democrat, as quoted by Denver7.

In late 2021, New York City opened the nation’s first overdose prevention center, which came a year after the city suffered from more than 2,000 drug overdose deaths, the highest number in two decades.

The city, citing a report from its Health Department, estimated that the overdose prevention centers could prevent as many as 130 deaths per year.

“New York City has led the nation’s battle against COVID-19, and the fight to keep our community safe doesn’t stop there. After exhaustive study, we know the right path forward to protect the most vulnerable people in our city. And we will not hesitate to take it,” said Bill de Blasio, then the mayor of New York City. “Overdose Prevention Centers are a safe and effective way to address the opioid crisis. I’m proud to show cities in this country that after decades of failure, a smarter approach is possible.” 

A study released last year found that NYC’s overdose prevention centers have done their job.

“Between November 30, 2021, and January 31, 2022, 613 individuals used OPC services 5975 times across 2 sites,” read the study, which was conducted by the NYC Health Department.

“During the first 2 months of OPC operation, trained staff responded 125 times to mitigate overdose risk. In response to opioid-involved symptoms of overdose, naloxone was administered 19 times and oxygen 35 times, while respiration or blood oxygen levels were monitored 26 times. In response to stimulant-involved symptoms of overdose (also known as overamping), staff intervened 45 times to provide hydration, cooling, and de-escalation as needed. Emergency medical services responded 5 times, and participants were transported to emergency departments 3 times. No fatal overdoses occurred in OPCs or among individuals transported to hospitals,” the study continued. “More than half of individuals using OPC services (52.5%) received additional support during their visit. This included, but was not limited to naloxone distribution, counseling, hepatitis C testing, medical care, and holistic services (eg, auricular acupuncture).”

It remains to be seen whether the facilities get approved in Colorado, where some Republicans have already expressed wariness.

“You’re basically sending a message that, ‘Hey, it’s OK to do this,’” said GOP state House Rep. Gabe Evans, as quoted by the Associated Press. 

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A new overdose reversal drug is arming first responders with a more powerful tool for fentanyl overdoses.

Zimhi—an FDA-approved high-dose naloxone injection—was recently released for the treatment of fentanyl overdoses. It delivers a higher, intramuscular immediate dose of naloxone, a higher dose than Narcan.

Narcan, the common brand name of naloxone, an opioid antagonist, has saved lives by reversing the effects of an opioid overdose in spray form. But even Narcan is no match for fentanyl, in some cases. A stronger antidote was needed.

US WorldMeds, a pharmaceutical company, announced the release of Zimhi in a press release, and highlighted a specific event: Clinical counselor Charles Pemberton regularly carried a trauma bag in his truck which contained naloxone. When Pemberton saw a driver passed out at a fast-food restaurant drive-thru in front of him, he administered two doses of naloxone, and probably saved that person’s life.

“At that moment, all my training kicked in,” Pemberton said. “It wasn’t until later that I felt relief that I had naloxone on hand.”

Pemberton added that substance abuse issues tend to come up during the holidays. “Make sure to ask questions and listen, but don’t lecture,” Pemberton said.

The National Institute on Drug Abuse reports that opioid overdose deaths continue to rise annually—primarily with fentanyl. Over 107,000 people in the United States died from a drug overdose in 2021, usually involving opioids. The DEA reports more overdoses are happening as criminals mass-produce fake pills containing fentanyl that mimic other pills.

Adamis Pharmaceuticals Corporation developed Zimhi. It can be used on the fly—rapidly pulling off the cap and inserting the needle into the thigh.

“Naloxone is an opioid antagonist that is used to temporarily reverse the effects of an opioid overdose, namely slowed or stopped breathing,” the U.S. Surgeon General Jerome Adams said. “Expanding the awareness and availability of this medication is a key part of the public health response to the opioid epidemic. Naloxone is a safe antidote to a suspected overdose and, when given in time, can save a life.”

WJXT News4JAX reports that Zimhi was released because Narcan wasn’t enough to revive people in some cases because opioid overdoses are becoming more challenging.

Narcan is a 4 mg nasal spray, and patients are only getting about 2 mg. But Zimhi delivers 5 milligrams of naloxone intramuscularly, and as soon as it’s injected, they receive the full 5 mg immediately.

“Fentanyl, over the past year, they’ve come up with different strands of it to where it’s almost 100 times stronger than what the fentanyl was a year ago,” said Chris Chodkowski, a trauma therapist.

“Even the regular people that just smoke marijuana, if they’re getting it off the street, we’re seeing it laced with fentanyl here in Palm Beach County,” Chodkowski said.

Putnam County Sheriff Gator DeLoach mentioned an incident involving a child exposed to fentanyl by touch.

“It’s only been within the last few weeks that we had an infant that was exposed to a large dose of fentanyl that we believed was an incidental touch contact from the mother,” DeLoach said. “As a result, our deputies got on the scene, and they had to deliver multiple doses of Narcan.”

The FDA-approved drug arms first responders, caregivers, and community members with a stronger naloxone option in the fentanyl crisis.

Adamis Pharmaceuticals Corporation announced on October 18, 2021 that the U.S. Food and Drug Administration (FDA) approved Zimhi for use in the treatment of opioid overdose. Dr. Jeffrey Galinkin, an anesthesiologist, and former member of the FDA Advisory Committee for Anesthetics, Analgesics and Addiction Products, stated, “I am pleased to see this much needed high dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths. The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations.”

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As of Tuesday, certain naloxone products like NARCAN have been evaluated by the U.S. Food and Drug Administration and determined to be safe enough to potentially be sold over the counter in the near future.

“Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status,” the FDA announcement said.

For those who don’t know, NARCAN is basically a nasal spray that acts as an anti-opiate of sorts. Naloxone is used alongside buprenorphine in the drug Suboxone which is used to treat the symptoms of opiate withdrawal. The key difference in NARCAN is that it’s naloxone by itself at a relatively high dose, which has absolutely no potential for abuse on its own.

“Naloxone is a medicine that rapidly reverses an opioid overdose. It is an opioid antagonist. This means that it attaches to opioid receptors and reverses and blocks the effects of other opioids. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an opioid overdose. But, naloxone has no effect on someone who does not have opioids in their system, and it is not a treatment for opioid use disorder.” – Excerpt from the National Institute of Health website.

At the moment you aren’t necessarily required to have a prescription to obtain NARCAN but in most cases you need to get it directly from a pharmacist and it can be very expensive. I obtained four free doses through this program, but the point is most addicts simply don’t have the regular access to NARCAN that they require.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, M.D. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The FDA assessment won’t make NARCAN freely available just yet but it is an important first step toward making a dent in the 100,306 deaths of United States citizens from drug overdose in the 12 months leading up to April 2021. 

“This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone,” the FDA said.

If you or someone you love uses opiates, carrying NARCAN is an absolute necessity. The following is a list of signs a person might be experiencing an opiate overdose from the official NARCAN website:

• Unusual sleepiness or unresponsiveness
• Breathing will be slow or absent
• Slow heartbeat or low blood pressure
• Skin feels cold and clammy
• Pupils are tiny
• Nails and lips are blue

If someone is exhibiting these symptoms you simply aim the NARCAN nasal plunger into the person’s nose and press the plunger to release the naloxone. They may require two doses especially if more powerful opiates like fentanyl are involved. 

I realize people might be cautious to carry NARCAN if they don’t use opiates and don’t know anyone who does but trust me when I say that you absolutely know someone who uses opiates in secret and fentanyl is popping up in drugs that have nothing to do with opiates at all like cocaine or even cannabis in a couple isolated incidents. Carrying NARCAN can save the lives of your loved ones or even strangers and I tell everyone I know to carry it at all times.

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Scientists with a new research center at the University of Washington are working on a vaccine to help fight the opioid epidemic in a bid to stem the tide of overdose deaths that has swept the nation over the past two decades. 

Marco Pravetoni, the head of the new UW Medicine Center for Medication Development for Substance Use Disorders, is leading the effort to develop the vaccine. Similar to immunization against an invading pathogen, the vaccine under development would stimulate the body’s immune system to attack and destroy opioid molecules before they can enter the brain. 

Such a vaccine would not prevent drug cravings commonly experienced by those with opioid abuse disorder. But the treatment, if successful, would block the effects of opioids including euphoria, pain relief and even overdose, thus likely reducing abuse.

The new research center opened this month and has raised more than $2 million in initial funding. Pravetoni hopes to raise enough money to complete further research on the vaccine under development.

“What I’m hoping to achieve is pretty much every year, we’re going to start a new clinical trial,” Pravetoni told the Seattle Times in early January.

An Epidemic of Opioid Overdoses

In November, provisional data from the U.S. Centers for Disease Control and Prevention showed that during the 12-month period ending April 2021, 100,306 Americans died of drug overdoses. Synthetic opioids were involved in nearly two-thirds of the overdose deaths reported.

The overdose-reversal drug naloxone has been shown to save lives in emergencies. Additionally, treatments for opioid abuse disorder including methadone and buprenorphine can help those struggling with addiction, although opioid replacement therapy drugs have their own risk of addiction. New treatments could increase the chances of success for those struggling with opioid abuse, according to Rebecca Baker, director of the National Institutes of Health’s Helping to End Addiction Long-term Initiative, a program that has helped fund Pravetoni’s research.

“(Existing medications) don’t work for everyone. And a lot of people don’t stay on them in the long term,” Baker said. “Would the outcomes be better if we had more options?”

The University of Washington’s opioid vaccine project is building on research published in the journal Nature in 1974. In that study, a rhesus monkey had been trained to self-administer heroin and cocaine. After being given an experimental vaccine to block the effects of heroin, the monkey continued to use cocaine but greatly reduced its use of heroin, suggesting the vaccine had done its job.

That study led to further research into the possibility of creating a vaccine for nicotine addiction. Although early results appeared promising, human trials showed the treatment was only as effective as a placebo. A vaccine developed to fight cocaine addiction saw a similar fate, and neither treatment received approval from the Food and Drug Administration.

Kim Janda, a chemistry and immunology professor at Scripps Research Institute in California, has spent decades researching vaccines against addictive drugs. He believes that continued research could eventually produce an effective vaccine.

“We’ve learned a lot more [about] what is possible, what’s maybe not going to be as fruitful,” Janda said, adding that vaccines may not work against all drugs of abuse. “But if there’s enough money to put behind these vaccines, and you had the infrastructure to do it, then you could move it along fairly quickly.”

This year, Pravetoni and a researcher with Columbia University have launched the first Phase 1 clinical trial of a vaccine to prevent opioid abuse. The safety and efficacy of the vaccine, which is designed to block the effects of oxycodone, is being tested in people who are already addicted but not receiving the disease.

Is an Opioid Vaccine Worth the Cost?

But human drug trials are expensive. Pravetoni estimates that bringing an effective opioid vaccine to market could cost up to $300 million. Some addiction experts, including Dr. Ryan Marino, an emergency medicine physician and medical toxicologist at Case Western Reserve University in Ohio, wonder if the money could be better spent.

“It is true that more treatment options are generally better,” Marino told Filter. “But what doesn’t make sense to me—as someone who treats both overdose and addiction—is putting so much funding towards this when we already have an antidote for opioids, a long-acting opioid blocker and two other evidence-based treatment options for opioid use disorder that both reduce opioid use and prevent overdose.”

Harm reduction activists working on the ground with people who have substance abuse disorders say that limited funds could be spent more effectively. Jessica Blanchard, the founder of Georgia a mobile harm reduction program called 229 Safer Living Access, distributes safer sex supplies and naloxone provided by other groups. But she personally covers the other costs to administer the program, which limits its operations substantially.

“With funding, not only could I afford to buy in bulk, greatly reducing cost, but I could also give participants more supplies to share with those unable to make contact with the program,” Blanchard said. “I would pay program participants to do secondary distribution. (They) are the experts here. They express a desire to participate in distributing supplies and educating their peers. But without the ability to compensate them for their time and lived-experiential knowledge, I simply can not ask them to help.”

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