Opvee, the first nalmefene hydrochloride nasal spray, was given the go-ahead by the U.S. Food and Drug Administration for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
The nalmefene hydrochloride nasal spray has now received FDA clearance for the first time. With more than 103,000 documented death overdoses occurring in the 12 months ending in November 2022, drug overdose continues to be a serious public health concern in the United States, with synthetic opioids like illegal fentanyl being the main cause.
Acute opioid overdose is treated with nalmefene, an opioid receptor antagonist. Nalmefene can counteract the consequences of an opioid overdose, including respiratory depression, drowsiness, and low blood pressure (also known as hypotension), if it is given rapidly. The recently authorized drug is designed for use in healthcare and community settings and delivers 2.7 milligrams (mg) of nalmefene into the nasal cavity. It is accessible by prescription.
Studies on Opvee's safety and pharmacokinetics, as well as research in which opioids were used recreationally by participants, were used to support the drug's approval. Nasal discomfort, headaches, nausea, dizziness, hot flashes, vomiting, anxiety, exhaustion, throat irritation, nasal congestion, decreased appetite, skin redness (erythema), and excessive sweating (hyperhidrosis) are among the most frequent side events.
The following signs and symptoms of opioid withdrawal may appear in individuals who are using nalmefene hydrochloride if they are opioid-dependent: Body pains, diarrhea, tachycardia (rapid heartbeat), fever, sneezing, runny nose, goosebumps (piloerection), perspiration, yawning, nausea or vomiting, anxiety, restlessness, or irritability, shaking or trembling, stomach cramps, weakness, and elevated blood pressure are some of the symptoms that may be experienced.
This application was given priority evaluation status by the FDA, which speeds up the development and evaluation of medicines with the potential to significantly improve the safety or efficacy of their use in the diagnosis, treatment, or prevention of critical conditions.
Opiant Pharmaceuticals Inc. received permission from the FDA to market Opvee. The FDA's Overdose Prevention Framework outlines the organization's goals for taking effective, innovative steps to prevent drug overdoses and lower the number of fatalities. The framework has four aims, one of which is promoting harm reduction by working to make overdose reversal products more widely available and accessible.
