1. Pink Sheet

More Options For Opioid Overdose: Nasal Naloxone On Brink Of OTC Use, While Opiant And Orexo Stay Rx To Counter High-Potency Opioids

 
• 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. 

User fee goals are approaching for several proposed naloxone products. • Source: Shutterstock

After abuse-deterrent opioid formulations reached a dead-end, the US FDA is again seeing growth in applications for new products that address the opioid crisis, led by not one but two applications for over-the-counter naloxone nasal sprays for overdose reversal, 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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