The US Food and Drug Administration (FDA) approved Indivior PLC’s Opvee, a nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. 

Nalmefene is an opioid receptor antagonist, which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure. The newly approved product, which delivers 2.7 milligrams of nalmefene into the nasal cavity, is available by prescription and intended for use in health care and community settings.

“Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl,” says Mark Crossley, CEO of Indivior, in a release. “Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives.”

The approval of Opvee was supported by safety and pharmacokinetic studies, as well as a study in people who use opioids recreationally to assess how quickly the drug works. In a study of 61 opioid-experienced, non-dependent subjects, the effect of 2.7 milligrams of Opvee was assessed on remifentanil-induced respiratory depression. 

Following Opvee administration, the time to onset of reversal of respiratory depression was observed between 2.5 to five minutes, and full recovery of respiratory drive was manifested as early as five minutes after Opvee administration. The duration of action of nalmefene is as long as most opioids, including fentanyl. 

The most common adverse reactions include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose, decreased appetite, skin redness, and excessive sweating.

The use of nalmefene hydrochloride in patients who are opioid-dependent may result in opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, fast heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

“On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups, and emergency responders,” says FDA commissioner Robert M. Califf, MD, in a release. 

Opvee is expected to be in the market in Q4 of 2023.

Indivior added Opvee to its portfolio with the acquisition of Opiant Pharmaceuticals Inc, which closed on March 2.