Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced positive top-line results from its confirmatory pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, for opioid overdose.
The study was conducted in 68 healthy subjects and compared OPNT003, nalmefene hydrochloride nasal spray, 3 mg, (“nasal nalmefene”), with an intramuscular nalmefene hydrochloride injection, 1 mg, which was the comparator previously agreed upon with the U.S. Food and Drug Administration (“FDA”). According to an initial analysis, the top-line data demonstrated that nasal nalmefene achieved significantly higher plasma concentrations compared to an intramuscular injection (p<0.0001). The time for nasal nalmefene to achieve maximum plasma concentrations (Tmax) was consistent with data from the previously completed pilot study (~15 minutes). The maximum plasma concentration (Cmax) was higher than observed in the pilot study, and the plasma half-life of nasal nalmefene (~11 hours) was consistent with reported values following other routes (oral and parenteral) of administration. Naloxone, currently the only FDA-approved treatment for opioid overdose, has a half-life of approximately 2 hours.
“We are very pleased with the results of this confirmatory PK study. Importantly, the data are consistent with the findings of our initial pilot study,” said Roger Crystal, M.D., CEO and President, of Opiant. “In the United States, where we’ve seen the opioid epidemic worsen during COVID-19, the nationwide spread of potent illicit synthetic opioids, such as fentanyl, which is 50 times stronger than heroin, with a half-life more than seven hours1, is driving significant numbers of opioid overdose deaths. A rescue agent with a rapid onset and a long half-life, is critical to saving lives from overdose. We now look forward to the PD data later in the year.”
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.