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Indivior Announces Publication Demonstrating that OPVEE® (nalmefene) Nasal Spray Rapidly Reverses Effects of Opioid-Induced Respiratory Depression in Head-to-Head Study Against Intranasal Naloxone
This head-to-head pharmacodynamic study in healthy volunteers examined the ability of both OPVEE and intranasal naloxone to reverse opioid-induced respiratory
About this update from Indivior Pharmaceuticals, Inc.
[{"type":"text","content":"This head-to-head pharmacodynamic study in healthy volunteers examined the ability of both OPVEE and intranasal naloxone to reverse opioid-induced respiratory depression, which is the shallow and slow breathing associated with an opioid overdoseIn this model, OPVEE 2.7mg reversed respiratory depression to 95% of pre-opioid baseline within 5 minutes; a similar reversal following a 4 mg dose of intranasal naloxone required 20 minutesRICHMOND, Va., March 11, 2024 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV) today announced results from a pharmacodynamic study demonstrating that OPVEE® rapidly reverses opioid-induced respiratory depression, which is the major cause of deaths due to opioid overdose. The study, \"Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone\", was published in the Journal of Clinical Pharmacology (Reversal of Opioid‐Induced Respiratory Depression in Healthy Volunteers: Comparison of Intranasal Nalmefene and Intranasal Naloxone - Ellison - The Journal of Clinical Pharmacology - Wiley Online Library) and is the first head-to-head comparison examining the effects of 2.7 mg intranasal (IN) nalmefene (OPVEE) and 4 mg IN naloxone on opioid-induced respiratory depression. This study was a part of the OPVEE development program and reviewed by the FDA as part of the approval process.\n\n \n \n \n \n \n \n\n \nThis study met the primary endpoint by demonstrating that OPVEE reversed the respiratory depression produced by remifentanil, a potent synthetic opioid related to fentanyl, within the first 5 minutes following administration. Both OPVEE and IN naloxone produced a time-dependent reversal of the opioid-induced respiratory depression 2.5 to 20 minutes post administration. Point estimates favored OPVEE, demonstrating non-inferiority and superiority to naloxone. After OPVEE administration, subjects' minute ventilation (a measure of the amount of air that enters the lungs per minute) reached approximately 95% of the pre-opioid baseline within 5 minutes and maintained this robust reversal through the initial 20-minute monitoring period. By contrast, naloxone required 20 minutes to restore respiration to levels equaling those observed 5 minutes after OPVEE. There is an urgent need for rapid acting reversal agents because synthetic opioids, l...