Indivior receives FDA nod for Opvee
The Food and Drug Administration has approved Indivior’s Opvee (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older.
Opvee contains nalmefene, an opioid receptor antagonist that provides fast onset and long-duration reversal of opioid-induced respiratory depression, the primary cause of opioid overdose injury and death.
"Opvee's 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," said Mark Crossley, CEO of Indivior. "Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives."
[Read more: Emergent BioSolutions receives FDA OK for OTC Narcan Nasal Spray]
"Despite our collective effort to stem opioid abuse in America, addiction can happen to anyone, and millions of people are at risk for not only opioid overdose, but also poisoning from illicit synthetic opioids such as fentanyl," said Jerome Adams, executive director of Health Equity Initiatives at Purdue University. "With Opvee, first responders will have a fast and long-acting rescue medication option to combat the current opioid epidemic and save lives."
"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," said FDA Commissioner Robert Califf. "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."
The speed of action, long duration and high potency of fentanyl and other synthetic opioids are driving unprecedented overdose deaths across a broader range of ages, and they are now a leading cause of death for people ages 18 to 45. In addition, for each opioid-induced fatality, it has been estimated that additional non-fatal overdoses can lead to long-term physical and mental disability, the company said.
[Read more: Teva debuts generic Narcan]
"I have seen firsthand the devastating impact of the opioid crisis on college campuses and in emergency rooms," said Madeline Hilliard, founder of Team Awareness Combating Overdose and DopaGE. "The FDA approval of Opvee is good news for everyone impacted by the overdose crisis. In fact, it uses the same device as currently available nasal overdose reversal agents on the market."
Opvee is expected to be in the market in Q4 of 2023.