The U.S. Food and Drug Administration has approved the first generic naloxone hydrochloride nasal spray. The spray is called Narcan and is a life-saving medication that can stop or reverse the effects of an opioid overdose.
According to the Centers for Disease Control and Prevention, about 400,000 people have died from an opioid overdose between 1999 to 2017. On average, 130 Americans die every day from opioid overdoses--a class of drugs that include prescription medications such as fentanyl, oxycodone, hydrocodone and morphine. Some opioids include illegal drugs such as heroin which contains fentanyl or derivatives of fentanyl.
“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 Douglas Throckmorton, M.D., deputy center director for regulatory programs in the 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.”