FDA Approves First Generic Naloxone Nasal Spray

The nasal spray does not require assembly and delivers a consistent, measured dose when used as directed, and the product can be used for adults or children and is easily administered by anyone, even those without medical training.

The U.S. Food and Drug Administration on April 19 granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, the medication that can stop or reverse the effects of an opioid overdose. The agency reported it is also 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 nasal spray does not require assembly and delivers a consistent, measured dose when used as directed, and the product can be used for adults or children and is easily administered by anyone, even those without medical training, according to FDA. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

"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. 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 Dr. Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research. "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. We're taking many steps to improve availability of naloxone products, and we're committed to working with other federal, state and local officials as well as health care providers, patients, and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction."

The announcement said the FDA approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, though generic injectable naloxone products have been available for years for use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

The agency cited CDC data that almost 400,000 people in the United States died from an opioid overdose from 1999 to 2017 and, on average, more than 130 Americans die every day from overdoses involving opioids.

The agency's priorities to address the opioid crisis included decreasing exposure to opioids and preventing new addiction cases; fostering the development of novel pain treatment therapies; supporting treatment of those with opioid use disorder; and improving enforcement and assessing benefit-risk.

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