Indivior today announced that the US Food and Drug Administration (FDA) approved 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, as manifested by respiratory and/or central nervous system depression. OPVEE contains nalmefene, an opioid receptor antagonist that provides fast onset and long duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death. OPVEE was designed to address the challenges of today’s opioid crisis.

“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, 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.”

OPVEE was approved via the 505(b)(2) pathway. In a first of its kind pharmacodynamic study (NCT04828005) in 61 opioid-experienced, non-dependent subjects, the effect of 2.7 mg OPVEE was assessed on remifentanil-induced respiratory depression. Following OPVEE administration, the time to onset of reversal of respiratory depression was observed between 2.5 to 5 minutes and full recovery of respiratory drive was manifested as early as 5 minutes after OPVEE administration. The duration of action of nalmefene is as long as most opioids, including fentanyl. These attributes are well-suited to address the challenges of today’s opioid overdose crisis.

“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, MD, MPH, Executive Director of Health Equity Initiatives, 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 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. For each opioid-induced fatality, it has been estimated that there are an additional 6.4-8.4 non-fatal overdoses that can lead to long-term physical and mental disability.

“I have seen firsthand the devastating impact of the opioid crisis on college campuses and in emergency rooms,” said Madeline Hilliard, Founder, Team Awareness Combating Overdose (TACO) 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.”

A federally funded contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, for up to $10.8 million, combined with a $7.4 million U01 “grand opportunities in medications development” grant received from the National Institute on Drug Abuse (NIDA), supported the development of OPVEE. The contract (number HHSO100201800029C) with BARDA was intended to develop OPVEE for reversal of opioid overdoses in the community and as a medical countermeasure and reversal agent in the event of a chemical attack using synthetic opioids.