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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Israeli biopharmaceutical company Madrigal Mental Care will unveil novel nanotechnology to deliver psilocybin via nasal spray for the treatment and prevention of post-traumatic stress disorder (PTSD) at Biomed Israel 2022, on May 10-12, 2022, at the David InterContinental Hotel in Tel Aviv, Israel, according to a May 9 press release.

Biomed Israel is a broad celebration of the life science and technology industries. At past events, the event attracted over 6,000 attendees, with 1,000 attending internationally from over 45 countries.

The novel nasal spray system enables nose-to-brain delivery of organic nanoparticles that encapsulate molecules of psychedelic substances—in this case, psilocybin. This nasal spray delivery system can also be used to deliver ketamine, mescaline, MDMA, and other psychedelics.

The nanotechnology was invented by Prof. Amnon Sintov, Department of Biomedical Engineering at Ben-Gurion University of the Negev (BGU) with licensing from BGN Technologies, the Technology Transfer Company of BGU.

“An increasing number of studies point to the advantages of using psychedelic drugs for the treatment of psychiatric disorders such as PTSD, depression, anxiety, obsessive compulsive disorder, and even addiction, with low doses,” Professor Sintov said. “Due to their powerful effect on the human brain, it is imperative to be able to deliver these drugs in a safe manner and in precise doses. Our novel nanotechnology platform enables encapsulation of precise drug doses in nanoparticles that are delivered directly to the brain via an intranasal spray, in a very efficient, fast, and safe manner.”

An increasing number of studies are exploring the use of psilocybin for the treatment of depression, end-of-life care, and PTSD. Since psilocybin is an 5-HT2A agonist, it’s being explored for its usefulness in many of these areas. The brain’s cortex is full of 5-HT2A receptors–notably in areas that control reflection, imagination, and introspection.

“Our technology ensures a focused and fast delivery of accurate doses of psychoactive substances. The nanoparticles are biodegradable and provide a significant advantage over common practices in terms of stability and accuracy,” David Gabay, Co-Founder, and Chairman of Madrigal Mental Care said. “In vitro studies, which were carried out by Prof. Shimon Ben-Shabat from the Department of Biochemistry and Pharmacology at BGU, show that the psilocybin doses used in the nanoparticles have a beneficial effect on inflamed brain cell cultures. We are currently beginning preclinical trials with rodents with the aim of achieving efficacy and safety approvals in order to begin first-in-human clinical trials next year. We have great confidence that this novel technology […] will propel forward the field of psychedelic-based treatments, for the benefit of millions of people around the world coping with chronic and acute psychiatric conditions such as PTSD and depression.”

Leadership acknowledged the growing need for alternative therapies that are needed when conventional therapies fall short, for conditions like treatment-resistant depression.

Dr. Galit Mazooz Perlmuter, Senior Vice President of Business Development, Bio-Pharma at BGN Technologies, noted, “There is a vast need for better treatments for PTSD and other mental disorders. We have filed a patent application to protect this unique approach, which is an excellent example of the kind of breakthrough technologies originating from top scientists at the Ben-Gurion University.”

As it turns out, the benefits of microdosing psilocybin to treat depression, PTSD, and other disorders isn’t just a Reddit topic anymore, as we see it being applied in a scientific setting.

Regarding nasal sprays to deliver psychedelics, in the U.S., the FDA approved an esketamine nasal spray for use in approved clinics around the country.

Israel is also home to a proliferation of cannabis-related medical device development as well, thanks to the country’s advanced approach to cannabis research.

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