FDA approves generic over-the-counter naloxone nasal spray

The FDA has approved an abbreviated new drug application for naloxone hydrochloride nasal spray, paving the way for the opioid overdose treatment to be available without a prescription.

According to a release from Amneal Pharmaceuticals Inc., approval means the USP 4 mg formulation, a generic equivalent to OTC Narcan HCI nasal spray, can be purchased over the counter.

Naloxone HCl spray binds to opioid receptors to reverse or block the effects of opioids, restoring normal breathing patterns within 2 to 3 minutes for individuals whose respiration has slowed or ceased because of opioid ingestion.

Per statistics cited in the release, in 2022, synthetic opioids like fentanyl were responsible for more deaths under age 50 than any other cause, including heart disease, cancer, homicide, suicide, and other accidents. According to CDC statistics also cited in the release, the potential for another individual to intervene was present in 46% of overdose deaths.

“Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription,” Chirag and Chintu Patel, co-CEOs of Amneal, said in the release. “By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands of even more people who could potentially save countless families and communities from further heartache and loss.”