The U.S. Food and Drug Administration (FDA) has given its approval for Opvee, a nasal spray containing nalmefene hydrochloride, as an emergency treatment for known or suspected opioid overdose in adults and adolescents aged 12 and above.
Opvee is the first nalmefene hydrochloride nasal spray to be approved for use in healthcare and community settings.
Opvee is similar to naloxone, the life-saving drug commonly known as Narcan that has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers. Both work by blocking the effects of opioids in the brain, which can restore normal breathing and blood pressure in people who have recently overdosed.
This approval is part of the FDA’s efforts to promote harm reduction and develop new products for opioid overdose reversal.
The announcement has been welcomed by Shatterproof, a national nonprofit organization focused on combating the addiction crisis in the United States.
“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.”
Illegally manufactured fentanyl, an extremely potent synthetic opioid, is increasingly contaminating the drug supply in the U.S. Opvee will provide communities, harm reduction groups, and emergency responders with an additional option for reversing opioid overdoses.
The Centers for Disease Control and Prevention (CDC) reported 109,680 overdose deaths in 2022, emphasizing the prevalence and dangers of fentanyl in illicit drugs.
“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.”
The FDA’s prompt review of new options is seen as an important step in finding innovative solutions to reverse fentanyl overdoses.
Drug overdose remains a significant public health issue in the United States, with over 103,000 fatal overdoses reported in the 12-month period ending in November 2022.
Synthetic opioids like illicit fentanyl are the primary contributors to these overdose deaths.
Nalmefene, the active ingredient in Opvee, is an opioid receptor antagonist used to treat acute opioid overdose.
When administered promptly, nalmefene can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure.
The newly approved nasal spray delivers 2.7 milligrams (mg) of nalmefene into the nasal cavity. It requires a prescription and is intended for use in healthcare and community settings.
The FDA’s approval of Opvee was based on safety and pharmacokinetic studies, as well as a study involving recreational opioid users to assess the drug’s speed of action. Common side effects of Opvee include nasal discomfort, headache, nausea, dizziness, hot flushes, vomiting, anxiety, fatigue, nasal congestion, throat irritation, decreased appetite, skin redness, and excessive sweating.
The use of nalmefene hydrochloride in patients dependent on opioids may result in opioid withdrawal symptoms, such as body aches, diarrhea, rapid heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
The FDA granted Priority Review designation to Opvee, which expedites the review process for drugs that have the potential to significantly improve the safety or effectiveness of treating, diagnosing, or preventing serious conditions.
The approval for Opvee was granted to Opiant Pharmaceuticals Inc.
The FDA’s Overdose Prevention Framework aims to prevent drug overdoses and reduce deaths. It focuses on four priorities, including promoting harm reduction by increasing the availability and access to overdose reversal products.