FDA Grants Approval For Teva’s Generic Nasal Spray For Opioid Overdoses

The US Food and Drug Administration (FDA) granted its final approval recently of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a medication that can stop or reverse the effects of an opioid overdose. The generic version is developed by Israeli pharmaceuticals company Teva.

According to the Centers for Disease Control and Prevention, 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. Almost 400,000 people died from an opioid overdose between 1999 and 2017, according to CDC data.

Naloxone nasal spray is one form of treatment for an opioid overdose. It does not require assembly and delivers a consistent, measured dose when used as directed.

“This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary,” the FDA said.

“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 Dr. Douglas Throckmorton, 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. 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.”

“All together, these efforts have the potential to put a vital tool for combatting 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.

A two-pack of Narcan retails for about $125. It was not immediately clear what Teva would be charging for its generic version.