RICHMOND, Va. – Indivior PLC (LSE/Nasdaq: INDV) announced results of a pharmacodynamic study indicating that its drug OPVEE® can rapidly reverse opioid-induced respiratory depression, a leading cause of opioid overdose death. The study, comparing intranasal nalmefene (OPVEE) with intranasal naloxone, was published in the Journal of Clinical Pharmacology.
The study met its primary endpoint by demonstrating 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 about 95% of pre-opioid baseline within five minutes of OPVEE administration.
In the study, 69 healthy volunteers experienced a reduction in minute ventilation after administration of remifentanil, a synthetic opioid. They were then treated with OPVEE or naloxone. OPVEE was non-inferior and superior to naloxone in the rate of reversal of opioid-induced respiratory depression.
Although adverse events were reported in more than 90% of subjects treated with both drugs, these were mostly mild to moderate and were attributed to remifentanil and experimental conditions rather than the drugs themselves. Common adverse events included headache, nausea, vomiting, and dizziness.
The urgency for fast-acting anti-opioid agents is underlined by the high number of opioid overdose deaths, which in the United States totaled more than 80,000 in the 12 months ending September 2023, with synthetic opioids such as fentanyl accounting for the majority part of these deaths.
OPVEE Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. It does not replace 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 results of 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.
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