FDA Approves Nasal Spray To Reverse Fentanyl Overdoses


The Meals and Drug Administration on Monday said that it had given regulatory approval to a nasal spray that has confirmed efficient in reversing overdoses attributable to fentanyl and different opioids.

The spray, often known as Opvee, is the “the primary nalmefene hydrochloride nasal spray for the emergency therapy of identified or suspected opioid overdose in adults and pediatric sufferers 12 years of age and older,” the FDA stated within the announcement, including that it is usually the “first FDA approval of nalmefene hydrochloride nasal spray for well being care and neighborhood use.”

The approval is one more step by policymakers in the USA to stem the tide of a nationwide drug disaster. Earlier this month, the U.S. Centers for Disease Control and Prevention reported that overdoses from fentanyl have spiked dramatically lately.

In Monday’s announcement, the FDA stated that drug overdose “persists as a significant public well being difficulty in the USA, with greater than 103,000 reported deadly overdoses occurring within the 12-month interval ending in November 2022, primarily pushed by artificial opioids like illicit fentanyl.” 

It is usually a part of the FDA’s “Overdose Prevention Framework,” a program launched final 12 months “to undertake impactful, artistic actions to forestall drug overdoses and scale back deaths.” Earlier this 12 months, the FDA approved the primary overdose-reversal product that may be obtained with out a prescription.

“The company continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage hurt discount by supporting the event of novel overdose reversal merchandise,” FDA Commissioner Robert M. Califf stated in Monday’s announcement. 

“On the heels of the FDA’s current approval of the primary over-the-counter opioid reversal agent, the supply of nalmefene nasal spray locations a brand new prescription opioid reversal choice within the arms of communities, hurt discount teams and emergency responders.”

The opioid disaster in the USA has prompted lawmakers all through the nation to enhance entry to probably life-saving medicine that can be utilized within the occasion of an overdose. One of the best-known is naloxone, which “has been used for many years to rapidly counter overdoses of heroin, fentanyl and prescription painkillers,” according to the Associated Press.

Opvee works equally to naloxone, the AP stated, and it has “achieved related restoration outcomes to Narcan, the main model of naloxone nasal spray.”

More from the FDA:

“The approval of Opvee was supported by security and pharmacokinetic research, in addition to a research in individuals who use opioids recreationally to evaluate how rapidly the drug works. The most typical opposed reactions embrace nasal discomfort, headache, nausea, dizziness, scorching flush, vomiting, nervousness, fatigue, nasal congestion and throat irritation, ache within the nostril (rhinalgia), decreased urge for food, pores and skin redness (erythema) and extreme sweating (hyperhidrosis). The usage of nalmefene hydrochloride in sufferers who’re opioid-dependent could lead to opioid withdrawal characterised by the next indicators and signs: physique aches, diarrhea, quick coronary heart price (tachycardia), fever, runny nostril, sneezing, goosebumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, belly cramps, weak point and elevated blood strain.”

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

“We merely can not tolerate extra pointless lack of life. We have now to behave with urgency and we have now to behave now,” stated Minnesota state Sen. Kelly Morrison, a Democrat, who’s sponsoring the invoice.

In its report released earlier this month, the CDC discovered that 69,943 folks died of a fentanyl-induced overdose in 2021, which equals to a price of 21.6 and is up significantly from 2016, when 18,499 died of an overdose from fentanyl at a price of 5.7.

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