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New Opioid Overdose Reversal Nasal Spray Receives FDA Approval
The US Food and Drug Administration (FDA) announced on Monday that it has approved a new opioid overdose reversal nasal spray for patients at least 12 years of age.
The medication, called Opvee, was developed by Opiant Pharmaceuticals, a global pharmaceutical company that was acquired by Indivior in March.
Opvee contains nalmefene, an opioid receptor antagonist that reverses remifentail-induced respiratory depression within 2.5 to 5 minutes, with full recovery of respiratory drive as early as 5 minutes after administration. The duration of action of nalmefene is as long as most opioids, including fentanyl. Opvee is the first nalmefene hydrochloride nasal spray to gain FDA approval for healthcare and community use.
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“The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” FDA Commissioner Robert M. Califf, MD, said in a news release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent [Narcan], the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups, and emergency responders.”
Indivior said in a news release that Opvee is slated to be made available by prescription in the fourth quarter of 2023.
While Opvee produces a similar effect to Narcan nasal spray, its longer acting period has caused concern for some practitioners within the field, who cite the intense withdrawal symptoms produced by opioid overdose reversal medications.
“The risk of long-lasting withdrawal is very real, and we try to avoid it," Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School and former adviser to the FDA on opioids, told the Associated Press. “We're not suffering from a naloxone shortage where we need to use an alternative. We have plenty of it and it works perfectly well.”
Opiant’s application to the FDA for Opvee was granted priority review designation, “which expedites the development and review of drugs that have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition,” per the administration.
Development of Opvee was backed by a federally funded contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the Department of Health and Human Services (HHS), for up to $10.8 million, along with a $7.4 million U01 “grand opportunities in medications development” grant from the National Institute on Drug Abuse (NIDA).
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