FDA grants priority review to over-the-counter Narcan nasal spray

December 7, 2022 1 minute read Add topic to email alert Get an email when new articles are posted Enter your email address to receive an email when new articles are posted . " data-actionsubscribe> subscribe Your request could not be processed. Please try again later.If this issue persists, please contact us customerservice@slackinc.com. back to helio The FDA has accepted an additional New Drug Application for Narcan nasal spray as an over-the-counter emergency treatment for opioid overdose. The agency has granted expedited review of the application. If approved, Narcan (Naloxone Hydrochloride, Emergent BioSolutions) will be the first of his 4 mg naloxone nasal sprays marketed in the United States (according to the manufacturer's press release). The FDA has accepted additional new drug applications for over-the-counter Narcan nasal sprays. Source: Adobe Stock The target date for the Prescription Drug Fee Act was set for March 29, 2023. “We are taking this step to address increasing and devastating numbers. Opioid Overdose and Death It's happening all over the country Robert G. Kramer, Emergent BioSolutions president and CEO said in a press release: "We look forward to working with the FDA to advance the application under Priority Review designation, providing scientific evidence supporting the efficacy and safety of Narcan nasal spray as an over-the-counter option for reversing opioid overdose." I believe in Approval of the application will take place in a few weeks FDA Announces Preliminary Evaluation Results indicates that certain naloxone products may be approved for over-the-counter use. For this reason, we encourage you to contact FDA as soon as possible. According to the release, the application included data from human factors studies that had been conducted, as well as "more than five years of post-market data to demonstrate the safe and effective use of Narcan." "Since its approval in 2015, Emergent has placed millions of prescription Narkan devices across the United States at risk in national, state and local government health departments, as well as public health clinics, fire departments and police departments. We've been distributing it to the first responders closest to people.” To release. “Accidental overdoses can happen to anyone, anywhere, at any time. Moving to OTC status will increase access to Narcan, and as the opioid epidemic continues to evolve, patient can meet the needs of Add topic to email alert Get an email when new articles are posted Enter your email address to receive an email when new articles are posted . " data-actionsubscribe> subscribe Your request could not be processed. Please try again later.If this issue persists, please contact us customerservice@slackinc.com. back to helio Opioid Resource Center Sources 1/ https://Google.com/ 2/ https://www.healio.com/news/primary-care/20221207/fda-grants-priority-review-to-overthecounter-narcan-nasal-spray The mention sources can contact us to remove/changing this article