The Food and Drug Administration on Monday approved Opvee, the first prescription nasal spray for opioid overdoses using nalmefene hydrochloride.
As opposed to products using naloxone, such as the 4 milligram spray approved for over-the-counter sale in March, nalmefene hydrochloride acts on a user’s opioid receptors longer and is, in general, more potent.
However, a longer half-life also means longer opioid withdrawal symptoms, such as nausea, diarrhea and muscle cramps. Symptoms that would last 30 to 40 minutes with a naloxone dosage can last more than six hours with nalmefene.
Opvee, which has 2.7 milligrams of nalmefene, was approved for use on patients suffering opioid overdoses ages 12 and older.
“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,” FDA Commissioner Robert Califf said.
Opvee’s producer, Indivior, plans to have the product on the market by the fourth quarter of 2023. The company sees Opvee as a potent weapon in the fight against fentanyl.
“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,” Indivior CEO Mark Crossley said.
From December 2021 to last December, 72,000 people in the U.S. died of an overdose linked to fentanyl.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.
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