The U.S. Food and Drug Administration (FDA) has announced a potential pathway to allow naloxone hydrochloride, known by the name brand Narcan, to be approved for over-the-counter use.
The Nov. 15 Federal Register notice, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” stated that the proposal would result in greater access to naloxone, a life-saving medication, that may prevent overdose deaths from opioids such as heroin, fentanyl and prescription opioid medications. Naloxone is easy to use and small to carry.
Naloxone, which works by blocking opioid receptors in the brain, prevented 26,463 people from overdosing between 1996 and 2014, according to the U.S. Centers for Disease Control and Prevention (CDC).
With the onset of the opioid epidemic, naloxone has become an increasingly important part of first responders’ toolkits. According to FDA Commissioner Robert M. Califf, M.D., the agency’s federal register notice is part of a continued focus on overdose prevention and reduction in substance abuse.
The notice submitted to the federal register included a preliminary assessment of potential non-prescription naloxone products. This assessment found that naloxone products such as a 4-milligram nasal spray and 2-milligram autoinjector could be “approvable as safe and effective” for non-prescription use. The nasal spray would be applied in the nose, while the autoinjector would either be applied to muscle tissue (intramuscularly) or beneath the skin (subcutaneously). According to the FDA, the intent of this assessment is to facilitate the development and approval of over-the-counter naloxone products.
While this assessment is a promising step forward, it will be up to private device manufacturers to demonstrate that these products are safe and effective. The FDA stated that the assessment “does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone.” With the assessment in place, the FDA has signaled to manufacturers that they are willing to review nonprescription naloxone products.
While the FDA’s actions are not definitive, Commissioner Califf was optimistic in his outlook, stating, “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone.”