FDA Okays First Generic Naloxone Nasal Spray for Opioid Overdose

The US Food and Drug Administration (FDA) has granted final approval for the first generic naloxone hydrochloride nasal spray (Narcan, Teva Pharmaceuticals) that can stop or reverse the effects of an opioid overdose.

The FDA tentatively approved this generic drug product in June 2018.

Teva’s generic naloxone nasal spray is the first for use in the community setting by individuals who have no medical training. The name-brand spray was approved in 2015.

Generic versions of injectable naloxone products that are used strictly in medical settings are already available.

Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. It can be used for both adults and children, the FDA said. The drug is sprayed into one nostril while the patient is lying on his or her back. Administration can be repeated if necessary.

The FDA is also planning steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose.

“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. 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,” Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a news release.

“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 coprescribed with all or some opioid prescriptions to reduce the risk of overdose death,” Throckmorton said.

“All together, these efforts have the potential to put a vital tool for combating opioid overdose in the hands of those who need it most — friends and families of opioid users, as well as first responders and community-based organizations,” he added.

Throckmorton noted that the agency is “committed to working with other federal, state, and local officials as well as healthcare providers, patients, and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

According to federal data, close to 400,000 people died from an opioid overdose from 1999 to 2017. On average, more than 130 Americans die every day from overdoses involving opioids, a class of drugs that includes prescription medications such as fentanyl, oxycodone, hydrocodone, and morphine, as well as illegal drugs such as heroin or drugs sold as heroin.

Last April, Surgeon General Vice Admiral Jerome Adams, MD, MPH, issued an advisory encouraging more individuals, including family, friends, and those who are personally at risk for an opioid overdose, to carry naloxone, as reported by Medscape Medical News.

https://www.medscape.com/viewarticle/912027