FDA Clears Narcan OTC for Opioid Overdoses

The FDA has approved the first prescription-to-OTC switch for naloxone, granting OTC approval to Emergent BioSolutions’ Narcan 4 mg (naloxone hydrochloride) nasal spray. Naloxone, which rapidly reverses the effects of opioid overdose, is the standard treatment for opioid overdose.

“We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential healthcare,” HHS Secretary Xavier Becerra said. “Today’s FDA action to allow access to naloxone without a prescription is another strong step forward in advancing HHS’s Overdose Prevention Strategy.”

Bobby Mukkamala, M.D.

While healthcare organizations praised the prescription to OTC switch, some are concerned about pricing of the OTC naloxone. “For this change to be most impactful, manufacturers must make the price of naloxone affordable, a crucial element for community organizations that are working to make it available,” Bobby Mukkamala, M.D., chair of the American Medical Association’s Substance Use and Pain Care Task Force, said in a statement.

In addition, health insurers should cover the life-saving drug, whether obtained through a prescription or OTC, AMA said. “All payers must continue or start to cover naloxone at no- or low-cost. There are many over-the-counter preventive health medications that are covered by insurance, such as aspirin, vitamin D, and fluoride. Naloxone should be added to that list.”

The FDA’s commissioner Robert M. Califf, M.D., encourages the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.

Emergent BioSolutions did not respond to Formulary Watch’s requests for comment on pricing of the OTC Narcan spray. However, the company anticipates the product will be available on U.S. shelves and at online retailers by late summer.

“In the meantime, the prescription product will remain in readily available supply through current access channels, including pharmacies through standing order or co-prescription laws and through community distribution,” Emergent BioSolutions said.

The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product, the FDA said. Manufacturers will be required to submit a supplement to their applications to effectively switch their products to OTC status, FDA said.

Narcan nasal spray was first approved by the FDA in 2015. According to the agency’s process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling.

The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

FDA officials said they would work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch.

Harm Reduction Therapeutics’ new drug application for RiVive, its low-cost OTC intranasal naloxone spray, was granted priority review in December 2022. The company anticipates an approval decision this July and, pending FDA approval, the company expects to launch in the United States in early 2024.

Meanwhile, the U.S. Bankruptcy Court approved Purdue Pharma providing Harm Reduction Therapeutics up to $9 million in additional financial support to fund commercial readiness for RiVive, the company said.

Harm Reduction Therapeutics is a nonprofit pharmaceutical company with a mission to prevent opioid overdose deaths by making low-cost intranasal naloxone available as an OTC product. Since 2018, Purdue has provided financial contributions, technical expertise, and rights to data.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, according to the FDA, primarily driven by synthetic opioids like illicit fentanyl.