Opiant Pharmaceuticals Inc (NASDAQ:OPNT) shares rose sharply Wednesday after the company disclosed positive top-line results of confirmatory pharmacokinetic study for OPNT003, nasal nalmefene, a novel investigational treatment for opioid overdose.
The Santa Monica-based Opiant says 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.
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 (T max ) was consistent with data from the previously completed pilot study (~15 minutes).
The maximum plasma concentration (C max ) 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.
Said CEO Roger Crystal. "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 hours, 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."
OPNT shares popped mid-morning Wednesday $3.32, or 25%, to $16.60.
