Adapt Pharma announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the New Drug Application (NDA) for Narcan (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose.
The NDA for Narcan Nasal Spray was recently submitted in July 2015 and it was previously been granted Fast Track designation by the FDA.
Narcan Nasal Spray, developed in collaboration with the National Institutes on Drug Abuse (NIDA), is designed to provide a dose of naloxone in a ready-to-use nasal spray formulation. Currently, naloxone is only FDA approved in injectable formulations.
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