- Opiant Pharmaceuticals Inc OPNT announced topline results from a pharmacodynamic (PD) study for OPNT003, nasal nalmefene for opioid overdose.
- This crossover study conducted in healthy volunteers compared 3 mg nasal nalmefene hydrochloride with 4 mg nasal naloxone hydrochloride in reversing respiratory depression produced by remifentanil, a synthetic opioid.
- The two study drugs were assessed by measuring changes in minute ventilation following administration of the respective study drug, with the primary endpoint at five minutes post-administration.
- Related: Opiant's Multi-Dose Nasal Nalmefene Shows Safety, Tolerability In Opioid Overdose.
- A preliminary analysis of the 50 subjects completing the study found that treatment with OPNT003 produced nearly twice the reversal of respiratory depression than produced by nasal naloxone at five minutes.
- The increases in minute ventilation were 5.745 L/min and 3.011 L/min, with nalmefene and naloxone, respectively.
- OPNT003 met the primary endpoint of non-inferiority to nasal naloxone.
- OPNT003, nasal nalmefene, is developed using a 505(b)(2) pathway. The Company expects to complete the U.S. marketing application filing in 2H of 2022.
- Price Action: OPNT shares closed 14.8% higher at $22.14 during premarket trading on the last check Thursday.
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