Opvee is an almefene hydrochloride nasal spray that is the first of its kind to be used to treat opioid overdoses in adults and children over the age of 12.
The FDA said that if the product is administered quickly, it can reduce the effects of opioid overdoses, including respiratory depression, sedation and low blood pressure.
“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 Califf said in a statement on Monday.
“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,” he added.
In March, the FDA, for the first time, approved a naloxone nasal spray, sold under the Narcan brand, for use without a prescription.
The FDA press release stated that drugs like fentanyl accounted for about 103,000 reported fatal overdoses in a 12-month period that ended in November 2022.
“In this overdose crisis, we are seeing fatalities that cut across demographics and patterns of drug use. There are unique populations and needs in different circumstances. We need more choices in our toolkit to help us respond, and importantly, broad access to those tools,” Nora Volkow, director of the National Institute on Drug Abuse, said in a statement.
“The FDA approval of intranasal nalmefene, after years of research from NIH and industry, is good news. Along with the other forms of overdose-reversing antidotes on the market, nalmefene can save lives. That’s the goal,” she added.