FDA Approves Naloxone Nasal Spray for Use by the Public

The US Food and Drug Administration (FDA) has approved the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, the medication that can stop or reverse the effects of an opioid overdose.

The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.

Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said, “The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.”

Generic injectable naloxone products have been available for years for use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017, and on average, more than 130 Americans die every day from overdoses involving opioids, a class of drugs that include prescription medications such as fentanyl, oxycodone, hydrocodone, and morphine, as well as illegal drugs such as heroin or drugs sold as heroin.

If naloxone nasal spray is administered quickly, it can counter the overdose effects, usually within minutes. However, it is important to note that it is not a substitute for immediate medical care, and the person administering naloxone nasal spray should seek further immediate medical attention on the patient’s behalf.

The FDA tentatively approved this generic drug product on June 8, 2018. Teva Pharmaceuticals USA Inc. has received final FDA approval to market generic naloxone nasal spray.