FDA Grants Final Approval for First Generic Naloxone Nasal Spray

Officials with the FDA have granted final approval to the first generic naloxone hydrochloride nasal spray for the treatment of opioid overdose, according to a press release. Teva previously received tentative approval by the FDA for the generic product in June 2018.

The name-brand nasal spray, Narcan (ADAPT Pharma), was approved by the FDA in November 2015.

Generic injectable naloxone products have been available for years; however, this approval marks the first generic naloxone nasal spray for use in a community setting by individuals without medical training. The approval comes after a 2-day advisory committee meeting held by the FDA in December 2018 that addressed new ways to improve the availability of naloxone, such as the development of over-the-counter naloxone products and additional generic options.

As part of ongoing efforts to quell the growing opioid epidemic, agency officials are seeking ways to improve accessibility of emergency overdose reversal treatments, according to Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for drug Evaluation and Research.

“In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone,” Dr Throckmorton said in the statement. “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 prescription to reduce the risk of overdose death.”

Additionally, as part of the US Department Health and Human Services’ public health emergency to address the opioid crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose.

According to the press release, naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. The product is available for use in adults or children. Patients who are opioid-dependent may experience severe opioid withdrawal as a result of naloxone nasal spray use.

Reference

FDA approves first generic naloxone nasal spray to treat opioid overdose [news release]. FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm. Accessed April 19, 2019.