The U.S. Food and Drug Administration has issued a notice that could help increase access to overdose-reversing naloxone drug products without the need for a prescription, paving the way to make more of them available for over-the-counter use.
Naloxone is a medication that blocks opiate receptors in the nervous system and rapidly reverses opioid overdoses when given to an overdosing person in a timely manner. In 2021, more than 107,000 Americans died of an overdose,from the Centers for Disease Control and Prevention. About 75% of those overdoses were related to opioids, including heroin and fentanyl.
"Today's action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone," said FDA Commissioner Robert M. Califf, M.D., in a Tuesday ."The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible."Naloxone is available in all 50 states, and, ,"many states have laws that allow pharmacists to dispense naloxone without a prescription." Community-based programs and syringe exchange services may also distribute naloxone.
The notice issued by the FDA, known as a Federal Register notice, aims to change some naloxone drug products from prescription status to nonprescription status, in addition to developing and approving new products. The notice includes a preliminary assessment stating that certain naloxone products, both nasal and injectable, may be approvable as"safe and effective for nonprescription use.
While the assessment is a step forward, it is not a final determination that certain naloxone products are safe and effective for nonprescription use, and it does not mandate that naloxone products immediately be made available for over-the-counter purchase. The final decision will be made by the FDA, based on additional data that would usually be submitted to the agency in an application for a proposed nonprescription naloxone product.
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