FDA approves Narcan (naloxone intranasal) for opioid overdose- Adapt Pharma

The FDA has approved Narcan (naloxone intranasal), from Adapt Pharma, the first FDA-approved nasal spray version of naloxone hydrochloride, to stop or reverse the effects of an opioid overdose.

Approval is based on clinical trials which showed that administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

Comment: In 2014, Evzio received FDA approval for the auto-injector naloxone product for use in opioid overdose - the only opioid antagonist approved for immediate administration by untrained people at that time. AntiOp is also developing an intranasal naloxone based therapy and received FDA Fast Track Designation in 2014.

Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. 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.