FDA takes first step to allow low-dose OTC naloxone on market

Regulatory NewsRegulatory News | 15 November 2022 |  By 

Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by the US Food and Drug Administration. Though the agency says it needs more data, a final determination could allow naloxone makers to get their product to market with fewer barriers to access than prescription versions of the drug.
Naloxone is used to treat opioid overdoses; proponents of the drug argue it should be more widely available to prevent overdose deaths. On 15 November, FDA published a notice that outlines the agency’s thinking on the safety and efficacy of non-prescription over-the-counter low-dose naloxone.
Regulators said that certain naloxone products, including nasal sprays that deliver up to 4mg of the drug and intramuscular or subcutaneous autoinjectors that deliver up to 2mg of the drug, may be safe and effective enough to be marketed without the need for a prescription.
“This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone,” FDA cautioned.
The agency has been working to develop strategies to address overdose deaths in the US as the nation responds to the ongoing opioid epidemic. FDA said its latest findings could spur the development and approval of non-prescription versions of the drug and improve access to naloxone.
"Today's action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone," said FDA Commissioner Robert Califf in a statement. "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."
While it may not be necessary to require a prescription for low-dose naloxone, FDA said it needs more information, such as product-specific data on the non-prescription user interface design, including packaging and labeling, to conclude whether that’s the case.
“By issuing this notice, the FDA is making application holders of certain prescription naloxone drug products aware of the preliminary assessment and the possibility that the agency may make a conclusive determination, through approval of a nonprescription naloxone drug product, that such products are safe and effective for use without a prescription,” the agency said. “The notice does not cover all naloxone products, as more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations (including vials, ampules or syringes without integrated needles) before a preliminary assessment with respect to those products can be reached.”
FDA is also looking for stakeholder feedback on whether there is enough safety and efficacy data to support allowing non-prescription OTC higher-dose naloxone products on the market.
Under the Federal Food, Drug, and Cosmetic Act (FD&C) Act drugs with the same active ingredient cannot be marketed as both prescription and non-prescription drugs without proving they are clinically meaningfully different. If the agency eventually determines that low-dose naloxone products may be sold without a prescription, it will label any products that continue to bear the “Rx only” symbol as misbranded.
Stakeholders can comment on FDA’s notice on regulations.gov until 15 January 2023.


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