The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects.
The FDA also said that it is planning new steps to prioritize the review of other generic drug applications that treat opioid overdose.
Nearly 400,000 people have died from an opioid overdose between 1999 and 2017, according to the Centers for Disease Control and Prevention. Approximately 130 Americans die every day from overdoses that involve opioids, including prescription medication and street drugs like heroin, which is often laced with fentanyl. Once an overdose occurs, reviving a person to full consciousness can be difficult. Breathing slows down and can even stop, which in turn can lead to death.
“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,” Dr. Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Altogether, 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 the 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.”
Naloxone nasal spray can counter overdose effects within minutes when administered in a safe timeframe, which is typically within minutes. Once naloxone is administered, further medical attention is needed.
The naloxone spray delivers a consistent, measured dose when used as directed. It can be used in adults or children and is easily administered by anyone. It is delivered by spraying into one nostril as the person who overdosed is lying on their back. Multiple doses can be given if needed.
The FDA approved the generic drug in June last year and Teva Pharmaceuticals has now received final FDA approval to market the generic naloxone nasal spray.
The U.S. Department of Health and Human Services has been committed to combating the opioid crisis and expanding the use of naloxone. The department announced in April 2017 that it had a 5-Point Strategy to combat the opioid crisis with efforts that included better addiction prevention, treatment and recovery services; better data; better pain management; better targeting of overdose-reversing drugs and better research.