FDA approves Opvee nasal spray for opioid overdoses

The Food and Drug Administration on Monday accredited Opvee, the primary prescription nasal spray for opioid overdoses utilizing nalmefene hydrochloride.

As against merchandise utilizing naloxone, such because the 4 milligram spray accredited for over-the-counter sale in March, nalmefene hydrochloride acts on a person’s opioid receptors longer and is, usually, stronger.

However, an extended half-life additionally means longer opioid withdrawal signs, akin to nausea, diarrhea and muscle cramps. Symptoms that will final 30 to 40 minutes with a naloxone dosage can final greater than six hours with nalmefene.

Opvee, which has 2.7 milligrams of nalmefene, was accredited to be used on sufferers struggling 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 mentioned.

Opvee’s producer, Indivior, plans to have the product in the marketplace by the fourth quarter of 2023. The firm sees Opvee as a potent weapon within the battle in opposition to 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 mentioned.