No new safety concerns for "Narcan" nasal spray for treating opioid overdoses: USFDA


eMediNexus    14 February 2023

On Monday, the staff reviewers of the US Food and Drug Administration did not raise any new safety issues with the over-the-counter Narcan nasal spray for treating opioid overdoses produced by Emergent BioSolutions Inc.


The first over-the-counter form of Narcan, or Naloxone, used to stop overdose deaths, will be discussed at a meeting of the FDA advisory council on Wednesday.


According to the reviewers, reducing the likelihood of misusing it for other conditions is one benefit of switching to OTC.


Some experts felt that the overdose epidemic might be affected if the committee voted in favor of their proposal. The group is anticipated to offer suggestions on ways to enhance the labeling of Emergents Narcan to guarantee a consumers safe and efficient drug usage in an emergency.


Maryann Mason, Associate Professor at the Feinberg School of Medicine at Northwestern University, said that labeling with a concept of limited literacy is a smart idea; therefore, it will be crucial to provide visuals and other aids.


The availability of Narcan could increase if the FDA approves it for over-the-counter use. This would be in line with the federal governments policy that allows pharmacists in some states to sell Narcan or Naloxone without a prescription.


But some medical professionals advised against this as Naloxone quickly reverses or inhibits the effects of opioids, making the necessity for expert supervision crucial.


Dr. Andre Waismann, the founder of Accelerated Neuro-Regulation Clinics, also agreed with the advice and said it must only be administered by professionals because patients may require immediate medical supervision.


(Source: https://health.economictimes.indiatimes.com/news/pharma/us-fda-staff-flag-no-new-safety-concerns-for-otc-opioid-overdose-drug/97904789)

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