22 May 2023 – Congratulations to Indivior on the US FDA approval of their opioid overdose rescue medication for natural and synthetic opioids, OPVEE® (nalmefene) Nasal Spray. PLC has been involved with the regulatory development of this product from the early stages with both Opiant Pharmaceuticals, the previous holder of OPVEE, and Indivior. OPVEE was filed and approved via the 505(b)(2) pathway by PLC on Indivior’s behalf.
Indivior Announces U.S. Food and Drug Administration Approval of OPVEE® (nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and Synthetic Opioids Like Fentanyl
- In the 12-month period ending in December 2022, over 79,000 people in the U.S. were reported to have died of an opioid overdose, of which 90% – approximately 72,000 – were linked to illicit synthetic opioids, mainly fentanyl1
- Approval based on data from a pharmacodynamic study demonstrating that OPVEE provides fast onset of reversal of respiratory depression induced by the synthetic opioid remifentanil2