The U.S. Food and Drug Administration (FDA) recently approved a new prescription nasal spray designed to treat the effects of opioid overdose.
According to a press release, the FDA has given final approval to Opiant Pharmaceuticals Inc. for Opvee, the first nalmefene hydrochloride nasal spray intended to treat suspected opioid overdose in patients ages 12 and older. The company was granted a priority review to expedite development and review of the new drug.
“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 FDA Commissioner Robert M. Califf, M.D., according to the press release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders.”
In the event of an acute opioid overdose, the drug can be used to deliver 2.7 milligrams (mg) of nalmefene, an opioid receptor antagonist, into the nasal cavity. Nalmefene can counteract the effects of an opioid overdose including respiratory depression, drowsiness, and low blood pressure (also known as hypotension). Common side effects of the drug can include "nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose (rhinalgia), decreased appetite, skin redness (erythema) and excessive sweating (hyperhidrosis)."
The use of nalmefene hydrochloride in patients who are opioid-dependent can result in opioid withdrawal characterized by symptoms including 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.
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.
