FDA grants approval for OTC opioid overdose treatment

03-Apr-2023 - Last updated on 03-Apr-2023 at 14:25 GMT

The naloxone hydrochloride nasal spray will be made available over-the-counter, therefore not requiring a prescription, in an effort to reduce deaths from opioid abuse.

Emergent Biosolutions’ Narcan (naloxone HCI) nasal spray becomes the first naloxone product that is approved for use without a prescription, after receiving approval from the US Food and Drug Administration (FDA). The drug is the standard treatment for opioid overdose.

As a result of the approval, the treatment will be sold over-the-counter (OTC) directly to consumers and will be available in drug stores, convenience stores, grocery stories, gas stations, and online.

In terms of how soon such products will be available and at what price, the FDA stated that it would be determined by the manufacturers. The agency added that it will work with all stakeholders to facilitate the continued availability of naloxone nasal spray products during the period where it will switch from prescription to OTC status.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA commissioner Robert Califf.

According to the agency, more than 101,750 reported fatal overdoses occurred in the 12-month period ending in October 2022. The FDA noted that this figure is primarily being driven by synthetic opioids, such as fentanyl.

Manufacturers that plan to create naloxone OTC products will need to submit a supplement to their applications to switch their products to OTC status.

The products will also require a change in the labeling for those products that reference Narcan as the listed drug product. Regarding the change of label, the agency noted that this would involve including easy-to-understand pictograms on how to use the drug.

The FDA’s decision arrived after Emergent applied to the FDA to sell Narcan as an OTC product. The application was given priority review status, which saw the FDA commit to make a decision by March 29.

In addition, the agency stated that it encouraged sponsors of certain naloxone products, such as Emergent, to submit applications for approval of OTC versions of their treatments.

At the time of its priority review for Narcan, the FDA stated that naloxone is a ‘critical tool’ because of its ability to reduce deaths from opioid overdose, with the nasal spray being particularly useful due to its simple method of delivery.