The Food and Drug Administration on Monday said that it had given regulatory approval to a nasal spray that has proven effective in reversing overdoses caused by fentanyl and other opioids.
The spray, known as Opvee, is the “the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older,” the FDA said in the announcement, adding that it is also the “first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.”
The approval is yet another step by policymakers in the United States to stem the tide of a nationwide drug crisis. Earlier this month, the U.S. Centers for Disease Control and Prevention reported that overdoses from fentanyl have spiked dramatically in recent years.
In Monday’s announcement, the FDA said that drug overdose “persists as a major public health issue in the United States, with more than 103,000 reported fatal overdoses occurring in the 12-month period ending in November 2022, primarily driven by synthetic opioids like illicit fentanyl.”
It is also part of the FDA’s “Overdose Prevention Framework,” a program launched last year “to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.” Earlier this year, the FDA approved the first overdose-reversal product that can be obtained without a prescription.
“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,” FDA Commissioner Robert M. Califf said in Monday’s announcement.
“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.”
The opioid crisis in the United States has prompted lawmakers throughout the country to improve access to potentially life-saving drugs that can be used in the event of an overdose. The best-known is naloxone, which “has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers,” according to the Associated Press.
Opvee works similarly to naloxone, the AP said, and it has “achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray.”
“The approval of Opvee was supported by safety and pharmacokinetic studies, as well as a study in people who use opioids recreationally to assess how quickly the drug works. The most common adverse reactions 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 may result in opioid withdrawal characterized by the following signs and symptoms: 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.”
In Minnesota, lawmakers are pushing to make Narcan available in schools.
“We simply cannot tolerate more needless loss of life. We have to act with urgency and we have to act now,” said Minnesota state Sen. Kelly Morrison, a Democrat, who is sponsoring the bill.
In its report released earlier this month, the CDC found that 69,943 people died of a fentanyl-induced overdose in 2021, which equals to a rate of 21.6 and is up considerably from 2016, when 18,499 died of an overdose from fentanyl at a rate of 5.7.