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Nasal Naloxone On Brink Of OTC Among Additional Opioid Overdose Options On US FDA's Plate

 
• By Bridget Silverman

Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids. 

• Source: Shutterstock

After abuse-deterrent opioid formulations reached a dead-end, the US Food and Drug Administration again is seeing growth in applications for new products that address the opioid crisis. In addition to two applications for OTC naloxone nasal sprays for overdose reversal, the agency is reviewing proposals for a potential Rx competitor and two prescription rescue products that aspire to address high-potency synthetic opioid overdose.

The OTC naloxone nasal spray NDAs from Emergent BioSolutions, Inc. and Harm Reduction Therapeutics followed years of FDA efforts...

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