FDA Approves Intranasal Naloxone for Opioid Overdose Reversal

The FDA has approved intranasal naloxone to help combat opioid abuse.

The US Food and Drug Administration (FDA) has approved intranasal naloxone to help combat opioid abuse in the United States.

More than 16 000 people died from prescription opioid overdoses in 2013, according to the Centers for Disease Control and Prevention (CDC).  Another 8000 died from heroin-related overdoses.

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The new technology, which will be marketed by Adapt Pharma Limited as Narcan, is the first of its kind to be approved by the FDA.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner of the FDA. “We cannot stand by while Americans are dying.”

Treatment with naloxone is currently administered via syringe or auto-injector. The new formulation and delivery system, which requires no assembly, is sprayed into one nostril while the patient is lying chest up.

“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,” Dr. Ostroff said.


FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose. 2015. US Food and Drug Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM473505. Accessed November 19, 2015.