- Opiant Pharmaceuticals Inc (NASDAQ: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.
Opiant Pharma Stock Surges On Positive Nasal Nalmefene Data In Opioid Overdose Study
Opiant Pharmaceuticals Inc (NASDAQ:OPNT) announced top-line results from its confirmatory pharmacokinetic study for OPNT003, nasal nalmefene, for opioid overdose. The 68-subject…
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