Shatterproof applauds the U.S. Food and Drug Administration (FDA) and U.S. health regulators’ approval of OPVEE® (nalmefene), an easy-to-use medication that can reverse fentanyl and other opioid overdoses amid the nation’s ongoing drug crisis. OPVEE is approved for patients aged 12 years and older and is available by prescription. It is similar to Naloxone (Narcan), the life-saving drug that has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers. Both medications work by blocking the effects of opioids in the brain, thus restoring normal breathing and blood pressure in people who have recently overdosed. OPVEE is expected to launch in October at the earliest.

Shatterproof is a national nonprofit organization focused on guiding communities with recovery information and resources, removing systemic barriers to recovery, mobilizing the country to advocate for change, and ending addiction stigma. For years, Shatterproof has encouraged the FDA to develop proactive solutions to address the opioid crisis. Additionally, Shatterproof has worked to advocate for legislation and increase awareness about the dangers of fentanyl. This includes releasing The Fentanyl Epidemic: State Initiative to Reduce Overdose Deaths, a research report that contains recommendations and state initiatives proven to reduce overdose deaths; advocating for The Fentanyl Sanctions Act (H.R. 2483/ S. 1044) to make trafficking fentanyl to the U.S. more difficult; and supporting the STOP Act, which upgrades postal service resources and education on fentanyl coming into the country.

"As the current opioid epidemic rages and claims the lives of thousands of people around the country, we need innovation in our rescue medicines and more people to carry them every day," said Jerome Adams, MD, MPH, Executive Director of Health Equity Initiatives and former Surgeon General. "OPVEE's nasal nalmefene formulation is part of the groundbreaking approach required to provide our first responders with the tools they need to fight this crisis."

Illegally manufactured fentanyl, a synthetic opioid that is 80 to 100 times more potent than morphine, is contaminating the U.S. drug supply at alarming rates. OPVEE will help place an opioid reversal option in the hands of communities, harm reduction groups and emergency responders.

“The CDC counted 109,680 overdose deaths in 2022. For overdose deaths to hover at such a high level demonstrates how fentanyl's ubiquity and potency continue to threaten the lives of illicit drug users,” said Kevin Roy, Chief Public Policy Officer of Shatterproof. “We need to innovate on solutions to reverse fentanyl overdoses, and FDA’s timely review of new options is an important component of that.”

To learn more about OPVEE, visit: https://www.indivior.com/en/media/press-releases/indiviorplc-opvee-approval