The newly FDA-approved prescription product delivers nalmefene to the nasal cavity to reverse the effects of opioid overdose.
The FDA has granted approval of nalmefene (Opvee; Indivior PLC), the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in patients 12 years and older, the agency announced in a press release. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
According to the FDA, drug overdose remains a major public health issue, with more than 103,000 reported fatal overdoses occurring in a 12-month period ending in November 2022. The agency states synthetic opioids, like illicit fentanyl, continually contribute to overdoses. The FDA granted this application Priority Review Designation, expediting the development and review process to provide a potential significant improvement in the safety or effectiveness of the treatment.
“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 Robert M. Califf, MD, FDA Commissioner. “The availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders.”
Nalmefene, an opioid receptor antagonist used to treat acute opioid overdose, can reverse the effects of opioid overdose including respiratory depression, sedation, and low blood pressure if administered quickly. The prescription nasal spray delivers 2.7 mg of nalmefene into the nasal cavity and is intended for health care and community-setting use.
Safety and pharmacokinetic studies supported the FDA approval of nalmefene, as did studies in individuals who use opioids recreationally to assess how quickly the drug works. Nasal discomfort, headache, nausea, dizziness, vomiting, anxiety, fatigue, nasal congestion and throat irritation, rhinalgia, decreased appetite, erythema, and excessive sweating are the most common adverse reactions, according to the FDA.
In patients who are opioid-dependent, the use of nalmefene may result in opioid withdrawal characterized by body aches, diarrhea, fast heart rate (tachycardia), fever, runny nose, sneezing, goosebumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
FDA approves prescription nasal spray to reverse opioid overdose. FDA. May 22, 2023. Accessed May 23, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-prescription-nasal-spray-reverse-opioid-overdose?utm_medium=email&utm_source=govdelivery