The Food and Drug Administration (FDA) has approved the first generic version of Narcan, the naloxone nasal spray designed to stop or reverse the effects of an opioid overdose. The brand-name Narcan was approved in 2015. Generic versions of the drug have already been available in the medical setting. Teva Pharmaceuticals’ recently approved generic naloxone nasal spray as the first approved for use in the community setting by individuals who have no medical training.
Teva’s naloxone nasal spray comes preassembled and delivers a measured dose of the drug when it is used as directed. Users need only to spray the drug into one nostril while the patient is lying on his or her back. The drug can be administered to both adults and children, and be repeated as needed.
“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,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
The FDA said it also will prioritize its review of generic drug applications for naloxone. Throckmorton added that the agency has “taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product.” The FDA is also exploring other ways to increase the availability of naloxone in the community, including whether naloxone should be prescribed along with all or some opioid prescriptions to reduce the risk over overdose death.
“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 said.
More than 130 Americans, on average, die each day from opioid overdoses. Last year, as the opioid epidemic reached new heights, Surgeon General Vice Admiral Jerome Adams, M.D., MPH, issued a health advisory that family, friends and those personally at risk for opioid overdose have naloxone on hand in the event of an overdose.