The First OTC Nasal Spray Form of Naloxone Approved by FDA to Treat Opioid Overdoses

In an effort to combat opioid overdoses, the FDA has just authorised the first naloxone medication available without a prescription. Naloxone hydrochloride nasal spray 4 mg (Narcan®, Emergent BioSolutions) was approved by the FDA, according to a news release. The FDA emphasised that access to other naloxone formulations and doses will continue to be restricted to those with a valid prescription.

Naloxone nasal spray has been approved for sale over the counter, which will boost the availability of the drug, make it easier to administer, and ultimately save lives by preventing opioid overdoses. In a statement, FDA Commissioner Robert M. Califf, MD, urged the producer to prioritise patient access by making the medicine widely accessible as quickly as feasible at a reasonable price.

The FDA reports that fatal drug overdoses remain a serious problem in the United States, with over 101,750 deaths expected in the year ending in October 2022. This increase is due mostly to the increased use of synthetic opioids like illegal fentanyl. The nasal spray may now be offered to the general public without a prescription, through retail outlets like supermarkets and convenience shops, as well as on the internet.

The manufacturer data showed that the medicine is safe and effective for use as advised in the proposed labelling, thus the FDA decided to make naloxone nasal spray available without a prescription. The FDA also noted that the producer provided evidence that the public may learn to use naloxone efficiently and safely without medical supervision.

In 2015, the FDA approved the first naloxone nasal spray prescriptions. Priority review was granted by the FDA in December 2022 after a second new drug application for Narcan's over-the-counter usage was submitted. The advisory committee members then all agreed in February 2023 to that the drug be made available without a prescription.

The FDA has made it clear that the existing authorised 4 mg generic naloxone nasal spray products that use Narcan as their reference listed drug product will need to have their labels revised in order to get clearance. In order to transition these medications to OTC status, the FDA has said that manufacturers must file a supplemental application. In addition, the clearance may have implications for the availability of additional brand-name naloxone nasal spray products with a 4 mg dose, but "determinations will be made on a case-by-case basis and the FDA may contact other firms as needed," according to the FDA.

During the transition of this medication from prescription status to nonprescription/OTC status, the FDA is working with our federal partners to assist assure continuing access to all forms of naloxone, according to PatriziaCavazzoni, MD, director, Centre for Drug Evaluation and Research, FDA. "Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through a Rx to OTC switch, and we encourage manufacturers to contact the agency as early as possible to initiate discussions."

The company Emergency BioSolutions expects to have Narcan for sale in its stores and on its website before the end of the summer. The corporation said in a press statement that "the prescription product will remain in readily available supply through existing access channels, including pharmacies through standing order or co-prescription laws and through community distribution."

Reference - https://investors.emergentbiosolutions.com/news-releases/news-release-details/us-fda-approves-over-counter-designation-emergent-biosolutions