The Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency said in a news release that it will also begin planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
"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,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in the release.
While generic injectable naloxone products have been available for years for use in a healthcare setting, FDA said this is the first generic naloxone nasal spray for use in a community setting by individuals without medical training. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.
According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017, and on average, 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 or drugs sold as heroin.
When an overdose occurs, if naloxone nasal spray is administered quickly, it can counter the effects, usually within minutes. No assembly is required, and it 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. FDA warns that the naloxone spray it is not a substitute for immediate medical care and overdose victims still need to professional assistance.
Going forward, FDA said it will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement similar to Generic Drug User Fee Act enhancements for complex products, such as pre-submission and midcycle meetings.
