Dive Brief:
- The Food and Drug Administration gave its approval this week for a nasal spray formulation of naloxone hydrochloride, which will be sold as Narcan for use in the emergency treatment of opioid overdose.
- The drug, manufactured by Adapt Pharma, is now the first non-injectable form of the drug legal in the U.S.
- The FDA noted a nasal spray version had been requested by emergency responders because it will be easier to administer and eliminate the risk of needlesticks.
Dive Insight:
The FDA's move fits in with numerous efforts across the U.S. to combat addictions and overdoses from opiates including heroin and doctor-prescribed painkillers.
"Combating the opioid abuse epidemic is a top priority for the FDA," acting FDA Commissioner Stephen Ostroff, MD, said in a prepared statement. "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."
The FDA noted without an approved nasal version, some emergency responders had resorted to creating their own using atomizers and injectable naloxone.
"Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA's high standards for safety, efficacy and quality," the FDA said, adding it provides a new alternative for family members of addicted drug users as well.