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Opiant beats path to FDA after nasal overdose drug matches Narcan

May 3, 2022

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Opiant Pharmaceuticals’ opioid overdose drug candidate has held its own against nasal naloxone in a trial of healthy volunteers, giving the company the data it needs to file for approval in the second half of the year.

The candidate, OPNT003, is a nasal formulation of nalmefene. The FDA approved an injectable form of the molecule in the 1990s, but that product was removed from the market in 2008. Opiant decided to try to resurrect the molecule in a nasal delivery format in the belief its half-life and affinity for opiate receptors may make it better than naloxone at treating overdoses on synthetic opioids such as fentanyl.

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