FDA Approves Nasal Spray for Reversing Fentanyl Overdoses

The Food and Drug Administration announced Monday that it had granted regulatory approval for a nasal spray that has been shown to be effective in reversing overdoses caused by fentanyl and other opioids.

The spray, known as Opvee, is “the first nalmefene hydrochloride nasal spray for emergency treatment of a known or suspected opioid overdose in adult and pediatric patients 12 years and older,” the FDA said in the announcement, adding that it was also the “first.” FDA Approval of Nalmefene Hydrochloride Nasal Spray for Healthcare and Public Use.”

The approval is another step by US policymakers to stem the tide of a nationwide drug crisis. Earlier this month, the US Centers for Disease Control and Prevention reported that fentanyl overdoses have increased dramatically in recent years.

In Monday’s announcement, the FDA said drug overdoses “remain a major public health concern in the United States, with more than 103,000 reported fatal overdoses in the 12 months ended November 2022, mostly due to synthetic drugs.” opioids such as illicit fentanyl.” .”

It’s also part of the FDA’s Overdose Prevention Framework, a program launched last year “to take effective, creative actions to prevent drug overdoses and reduce deaths.” Earlier this year, the FDA approved the first overdose reversal product available without a prescription.

“The agency continues to advance the FDA overdose prevention framework and is taking actionable steps that promote harm reduction by supporting the development of novel overdose-reversal products,” FDA Commissioner Robert M. Califf said in Monday’s announcement.

“Following the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray opens 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 across the country to increase access to potentially life-saving drugs to use in the event of an overdose. Best known is naloxone, which according to the Associated Press “has been used for decades to quickly counteract heroin, fentanyl, and prescription painkiller overdoses.”

Opvee works similarly to naloxone, the AP said, and it has “achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray.”

More from the FDA:

“Opvee’s approval 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 side effects include nasal discomfort, headache, nausea, dizziness, flushing, vomiting, anxiety, tiredness, nasal congestion and throat irritation, nasal pain (rhinalgia), decreased appetite, skin redness (erythema), and excessive sweating (hyperhidrosis). Use of nalmefene hydrochloride in opioid-dependent patients can lead to opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, chills or tremors, abdominal cramps, weakness and increased blood pressure.”

In Minnesota, lawmakers are pushing to make Narcan available in schools.

“We simply cannot tolerate any more unnecessary loss of life. We need to act urgently, and we need to act now,” said Minnesota State Senator Kelly Morrison, a Democrat who supports the bill.

In its report released earlier this month, the CDC found that 69,943 people died from a fentanyl-induced overdose in 2021, a rate of 21.6 and a significant increase from 2016 when 18,499 people had a rate of 18,499 5.7 died from a fentanyl overdose.