First Generic for the Opioid Antagonist Narcan Approved by the FDA

Brian Williams, PharmD

On April 19, the Food and Drug Administration (FDA) granted final approval of the first generic for naloxone nasal spray, more commonly known as Narcan. Naloxone is an opioid antagonist and this life-saving medication can stop or reverse the effects of an 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,” said Douglas Throckmorton, M.D. (deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research) in a statement released by the FDA on April 19, 2019.

This approval is the first generic naloxone nasal spray for use in a community setting by individuals lacking medical training. Generic injectable naloxone products have previously been available in health care settings.

According to CDC statistics, almost 400,000 people died from an opioid overdose between 1999 and 2017. On average, more than 130 Americans die from an overdose every day from both prescription (e.g., fentanyl, oxycodone, hydrocodone, morphine) and illicit (e.g., heroin) opioids. An opioid overdose leads to breathing becoming shallow or stopping completely, which leads to death without medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.

As part of ongoing efforts from the U.S. Department of Health and Human Services to combat the opioid crisis and expand the use of naloxone, the Department announced in April 2017 its 5-Point Strategy to Combat the Opioids Crisis. Included in these efforts are better targeting of overdose reversing drugs. In April 2018, Surgeon General VADM Jerome Adams issued an advisory encouraging more individuals, including family, friends and those who are personally at risk for an opioid overdose to carry naloxone.

The FDA has determined that further expanding availability of and access to overdose reversal drugs could help address the public health emergency. Approval of generic naloxone products is one way the FDA is working to increase access to these life-saving treatments.

What does this mean to you?

Opioids continue to be some of the most commonly prescribed medications in work comp, despite significant improvement over the years. For injured workers who experience an overdose, naloxone may save their lives. For any questions you may have about Narcan, naloxone, or opioids, please reach out to the myMatrixx clinical team at Clinical@myMatrixx.com