Just two months after Emergent BioSolutions made history by winning the FDA’s blessing to sell its opioid reversal medicine over the counter, a new treatment option has arrived in Indivior's Opvee.
The nod, which covers Opvee's use in people 12 years of age and older, marks the first approval for the medicine's active ingredient in nasal spray form. The molecule, nalmefene hydrochloride, was first approved in the 1990s in an injectable format but was later pulled from the market in 2008.
This time around, the FDA endorsed the drug based on new evidence that it can help combat rising overdose rates in the U.S.
Indivior, which closed its purchase of Opiant in March and picked up the medicine in that buyout, plans to launch Opvee in the fourth quarter of 2023.
The FDA's approval comes as overdoses attributable to synthetic opioids such as fentanyl are on the rise, with more than 103,000 reported in the U.S. in the 12-month period that ended last November. The spray, if administered quickly, can reverse the effects of opioid overdoses.
“The availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders,” FDA Commissioner Robert M. Califf, M.D., said in the agency’s statement.
In trials, the drug held its own against naloxone, the generic name for Emergent's popular overdose rescue drug Narcan. The results prompted Opiant to file its application for approval, which then secured an FDA fast-track designation.
The filing was also backed by the Biomedical Advanced Research and Development Authority, which put in $2.1 million to support the application last August.
For its part, Indivior agreed to purchase Opiant last November for an initial $145 million payment. The deal closed in March.
At the FDA, officials are advancing their response to the opioid and overdose epidemic, Califf added. The agency's Overdose Prevention Framework, which was introduced last August, targets unnecessary and prolonged prescriptions plus counterfeit drugs. It also promotes treatments for substance use disorders and education programs for physicians.
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