Opiant Pharma Stock Surges On Positive Nasal Nalmefene Data In Opioid Overdose Study

Opiant Pharmaceuticals Inc OPNT announced top-line results from its confirmatory pharmacokinetic study for OPNT003, nasal nalmefene, for opioid overdose.
The 68-subject study compared 3mg nalmefene nasal spray with 1 mg intramuscular nalmefene injection.
According to initial analysis, nasal nalmefene achieved significantly higher plasma concentrations compared to an intramuscular injection.
The time for nasal nalmefene to achieve maximum plasma concentrations was consistent with data from the previously completed pilot study (around 15 minutes).
The maximum plasma concentration was higher than observed in the pilot study. The plasma half-life of nasal nalmefene (~11 hours) was consistent with reported values following other administration routes (oral and parenteral).
Naloxone, currently the only FDA-approved treatment for opioid overdose, has a half-life of approximately 2 hours.
In April, Opiant initiated a pharmacodynamic study in healthy subjects comparing OPNT003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid remifentanil.
Topline data is expected in Q4 of 2021.
The company expects to submit a marketing application to the FDA by year-end or Q1 of 2022.
The development of OPNT003 is supported by grants from the National Institute on Drug Abuse and the Biological Advance Research and Development Agency.
Price Action: OPNT shares are up 38.44% at $18.35 during the premarket session on the last check Wednesday.