OPVEE shows rapid reversal of opioid effects in study
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RICHMOND, Va. – Indivior PLC (LSE/Nasdaq: INDV) has announced the results of a pharmacodynamic study indicating that its drug OPVEE® can quickly reverse opioid-induced respiratory depression, a major cause of death in opioid overdoses. The study, comparing intranasal nalmefene (OPVEE) with intranasal naloxone, was published in the Journal of Clinical Pharmacology.
The study met its primary endpoint by showing that OPVEE reversed respiratory depression within five minutes of administration, while naloxone took 20 minutes to achieve a similar effect. Minute ventilation, a measure of breathing, reached approximately 95% of the pre-opioid baseline within five minutes after OPVEE was administered.
In the study, 69 healthy volunteers experienced a reduction in minute ventilation after being administered remifentanil, a synthetic opioid. They were then treated with either OPVEE or naloxone. OPVEE was found to be non-inferior and superior to naloxone in the speed of reversing opioid-induced respiratory depression.
Although adverse events were reported in over 90% of subjects following both drugs, these were mostly mild to moderate and were attributed to the remifentanil and experimental conditions rather than the drugs themselves. Common adverse events included headache, nausea, vomiting, and dizziness.
The urgency for rapid-acting opioid reversal agents is underscored by the high number of opioid overdose deaths, which in the United States totaled over 80,000 in the 12 months ending in September 2023, with synthetic opioids like fentanyl accounting for most of these fatalities.
OPVEE nasal spray is indicated for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 and older. It is not a substitute for emergency medical care and is intended for immediate administration where opioids may be present.
Indivior is a global pharmaceutical company focused on developing treatments for substance use disorders and serious mental illnesses. The findings from this study were part of the OPVEE development program and were reviewed by the FDA during the approval process. This information is based on a press release statement.
