FDA Approves Nasal Spray To Reverse Fentanyl Overdoses

FDA Approves Nasal Spray To Reverse Fentanyl Overdoses

food and drug administration monday Said The company said it has granted regulatory approval to a nasal spray that has proven effective in reversing fentanyl and other opioid overdoses.

The spray, known as Opvee, is “the first nalmefene hydrochloride nasal spray for emergency treatment of known or suspected opioid overdose in adults and pediatric patients age 12 and older,” the FDA said. announcementadded that this is also “the first FDA approval of nalmefene hydrochloride nasal spray for medical and community use.”

The approval marks 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 surged dramatically in recent years.

In a statement Monday, the FDA said drug overdoses “remain a significant public health problem in the United States, with more than 103,000 fatal overdoses reported in the 12 months to November 2022.” , largely due to synthetic opioids such as illicit fentanyl.” ”

It is also part of the FDA’s Overdose Prevention Framework program. launched Last year’s goal was to “engage in impactful and creative action to prevent drug overdoses and reduce deaths.” Earlier this year, the FDA announced approved The first overdose control product available without a prescription.

FDA Commissioner Robert M. Calif said in a statement Monday, “The agency will continue to advance the FDA’s Overdose Prevention Framework and implement actions that promote harm reduction by supporting the development of new overdose-fighting products. We will take all possible measures,” he said.

“Following the recent FDA approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray puts a new prescription opioid reversal option in the hands of communities, harm reduction groups and first responders. will be given.”

In the wake of the opioid crisis in the United States, lawmakers across the country are being called on to improve access to a potentially life-saving drug that can be used in case of an overdose. The best known is naloxone, which “has been used for decades to rapidly combat heroin, fentanyl and prescription painkiller overdoses.” According to Associated Press.

The Associated Press said Opvee acts similarly to naloxone and “achieves recovery results similar to Narcan, the leading brand of naloxone nasal spray.”

Details from FDA:

“Opvee’s approval was supported by safety and pharmacokinetic studies, as well as studies evaluating the drug’s speed of action in people who use recreational opioids. The most common side effects include: , nasal discomfort, headache, nausea, dizziness, hot flashes, vomiting, anxiety, fatigue, nasal congestion and throat irritation, nasal pain (nasal pain), decreased appetite, redness of the skin (erythema), and excessive sweating. Use of nalmefene hydrochloride in opioid dependent patients can result in opioid withdrawal symptoms characterized by the following signs and symptoms: body aches, diarrhea, and increased heart rate ( tachycardia), fever, runny nose, sneezing, goosebumps (piloerection), sweating, yawning, nausea and vomiting, nervousness, restlessness and irritability, shivering and shaking, abdominal pain, weakness, increased blood pressure.

In Minnesota, legislators are pushing to make Narkan available in schools.

“We cannot tolerate any more unnecessary loss of life. Senator Morrison said.

In a report released earlier this month, the CDC found that 69,943 people will die from fentanyl overdoses in 2021. This equates to a death rate of 21.6, a significant increase from the death rate in 2016, when 18,499 people died from fentanyl overdoses. 5.7.

Alexandra Solorio
Introducing Alexandra, an accomplished cannabis writer who has passionately pursued her craft for a decade. Through a decade-long journey, Alexandra has cultivated a profound connection with the cannabis world, translating her expertise into captivating prose. From unraveling the plant's rich history to exploring its therapeutic marvels and legal evolution, she has adeptly catered to both connoisseurs and newcomers. An unwavering advocate, Alexandra's words not only enlighten but also advocate responsible cannabis use, establishing her as an indispensable industry voice over the past ten years.

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