The FDA has issued a notice in the Federal Register titled, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.” The agency says that its preliminary opinion is that autoinjectors with doses up to 2 mg and nasal sprays with doses up to 4 mg such as Narcan nasal spray could be appropriately approved as nonprescription drugs. Regarding higher dose products such as Kloxxado nasal spray, the agency says, “we have limited postmarketing experience to meaningfully inform whether they may be appropriate for nonprescription use.”
In its announcement of the notice, the agency states that, “To make its final determination, the FDA needs additional data, such as product-specific data on the nonprescription user interface design, including packaging and labeling” and is soliciting public comments “on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.”
In addition to soliciting public comment, the notice states that, “The Agency strongly encourages application holders of prescription naloxone products described in this notice to contact FDA as early as possible to initiate a discussion about a possible switch.” The FDA also notes its past actions meant to encourage development of OTC naloxone products, including its publication of a model Drug Facts Label in 2019 and extending the shelf life of naloxone nasal spray from 24 months to 36 months.
According to the Federal register notice, the FDA found that in 2021 more than 90% of naloxone sales at retail pharmacies were for nasal sprays compared to only about 50% in 2017, and nasal sprays accounted for more than 95% of all naloxone prescriptions dispensed from retail, mail order, and long-term care pharmacies.
FDA Commissioner Robert Califf commented, “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone. 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.”
Read the FDA press release.
Read the Federal Register notice.
