Some Naloxone Products May Be Safe, Effective Over the Counter, FDA Says

After a preliminary review, the FDA issued a notice on Tuesday suggesting that some lower-dose naloxone hydrochloride (Narcan) products may be safe and effective for use without a prescription.

Specifically, naloxone nasal spray up to 4 mg and the intramuscular or subcutaneous naloxone autoinjector up to 2 mg “have the potential to be safe and effective” for over-the-counter access, the FDA wrote.

“We believe the prescription requirement for these naloxone products might not be necessary for the protection of the public health,” the agency added. However, more “product-specific data” related to the nonprescription user interface design, such as packaging and labeling information, is needed to “make a conclusive determination.”

The FDA also underscored that the notice does not represent a mandate for prescription naloxone products to immediately transition to over-the-counter status.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, MD, in a press release.

If administered quickly, naloxone, a nonselective opioid receptor antagonist, can help reduce the risk of opioid overdose deaths and mitigate the health impacts of an overdose, the agency explained. To date, there are no naloxone products approved for nonprescription use by the FDA.

The information in the notice is intended to help drug manufacturers develop and gain approval for nonprescription naloxone products, and help transition naloxone products to over-the-counter status.

According to the notice, the “primary ways” of bringing a nonprescription drug to market include:

• Using the over-the-counter drug review process under section 505G of the Federal Food, Drug, and Cosmetic (FD&C) Act with respect to OTC monograph drugs
• Using the application process under section 505 of the FD&C Act or, for a biological product regulated as a drug, under section 351 of the Public Health Service Act

However, “a drug originally approved as a prescription drug may be switched to nonprescription status if FDA finds that prescription requirement for such drug is not necessary for the protection of the public health,” the agency added. For a switch from prescription to be allowed, the FDA must agree that the data are “sufficient” to indicate that the drug can be used safely and effectively by consumers “without the supervision of a licensed healthcare practitioner.”

Typically, this requires the manufacturers to complete studies demonstrating that their products can be used without such supervision, and requires Drug Facts Labeling that enables consumers to “self-select” and use the products safely and effectively.

The notice does not extend to all naloxone products, since more data on the safety and efficacy of nonprescription use of higher-dose naloxone products and products delivered via “other presentations” (such as vials, ampules, or syringes that lack integrated needles) are needed to complete a preliminary assessment, the FDA noted.

Under the FD&C Act, “simultaneous marketing” of one drug with the same active ingredients under both prescription and nonprescription status is prohibited, unless there is a clinically meaningful difference between the two products, the agency said.

The notice also included a request for comments within 60 days after publication in the Federal Register on Wednesday.

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