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FDA approves naloxone nasal spray

November 19, 2015
by Julie Miller, Editor in Chief
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Intranasal naloxone (Narcan) has been approved by FDA in a new nasal spray formulation. It’s significant because the needle-free design will provide caregivers and first responders with an alternative that’s easier to use than injectable naloxone to reverse opioid overdose.

FDA granted what is known as fast-track designation and priority review for naloxone as a nasal spray. Fast track expedites review of drugs that address an unmet medical need. The priority review program provides for an expedited review of drugs that offer a significant improvement in safety or effectiveness. The nasal spray formulation was approved in less than four months.

“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,” said Stephen Ostroff, MD, acting commissioner for FDA.  

Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally.

The National Institute on Drug Abuse (NIDA) is calling attention to the new formulation. See Director Nora Volkow discussing the naloxone approval in this video:

 

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