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 remedy of identified or suspected opioid overdose in adults and pediatric sufferers 12 years of age and older,” the FDA mentioned within the announcement, including that additionally it is the “first FDA approval of nalmefene hydrochloride nasal spray for well being care and neighborhood use.”
The approval is yet 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 mentioned that drug overdose “persists as a serious public well being concern 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, inventive actions to forestall drug overdoses and cut back deaths.” Earlier this 12 months, the FDA approved the primary overdose-reversal product that may be obtained with no 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 mentioned in Monday’s announcement.
“On the heels of the FDA’s current approval of the primary over-the-counter opioid reversal agent, the provision of nalmefene nasal spray locations a brand new prescription opioid reversal choice within the fingers 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 medication 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 shortly counter overdoses of heroin, fentanyl and prescription painkillers,” according to the Associated Press.
Opvee works equally to naloxone, the AP mentioned, and it has “achieved comparable restoration outcomes to Narcan, the main model of naloxone nasal spray.”
“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 shortly the drug works. The most typical adversarial reactions embrace nasal discomfort, headache, nausea, dizziness, scorching flush, vomiting, anxiousness, 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 fee (tachycardia), fever, runny nostril, sneezing, goosebumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, belly cramps, weak spot and elevated blood stress.”
In Minnesota, lawmakers are pushing to make Narcan available in schools.
“We merely can’t tolerate extra pointless lack of life. Now we have to behave with urgency and now we have to behave now,” mentioned 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 fee of 21.6 and is up significantly from 2016, when 18,499 died of an overdose from fentanyl at a fee of 5.7.
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