The FDA announced the approval of Adapt Pharma's Narcan as the first authorised nasal spray version of naloxone hydrochloride, which is used to stop or reverse the effects of an opioid overdose. The agency noted that until this approval, naloxone was only available in injectable forms, most commonly delivered by syringe or auto-injector.
"Combating the opioid abuse epidemic is a top priority for the FDA," commented Stephen Ostroff, the agency's acting commissioner. "While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose," Ostroff added.
The FDA noted that Narcan was approved in less than four months, after accepting Adapt Pharma's submission in September, and ahead of the product's prescription drug user fee goal date of January 20, 2016. The FDA granted Narcan fast-track designation and priority review.
According to the agency, clinical trial results demonstrated that administering Narcan in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved intramuscular injection of the drug, whilst achieving these levels in approximately the same time frame. Adapt Pharma, which originally licensed Narcan from Lightlake Therapeutics, noted that the product delivers a 4 mg dose of naloxone in a single 0.1 ml nasal spray.
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