Tuesday, February 21, 2023

FDA Advisory Panel Recommends Approval for Over-the-Counter Narcan

Last week the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously, 19-0, to recommend that Narcan (naloxone HCl) 4 mg nasal spray be made available without a prescription, Emergent BioSolutions announced. The medication reverses an opioid overdose by blocking the effects of opioids.

The FDA is not bound by the committees’ guidance but will take their advice into consideration when it makes its decision on whether to make the drug available over the counter (OTC). If approved, Narcan would be the first OTC naloxone product. The FDA’s decision is expected by March 29.

The recommendation comes after Emergent presented an overview of its OTC development program, medical need, human factors study data, and seven years of postmarketing safety data.

“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” said Joshua Lynch, D.O., E.M.T.-P., of the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, in the announcement. “The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”

According to a report in STAT, while Narcan’s cost varies widely, a two-pack of 4 mg spray typically costs between $35 and $65.

The report also noted that although the committee’s vote was unanimous, the FDA’s scientific advisors and agency leaders criticized Emergent, noting that the company’s user-friendliness tests did not include time limits and included language that may have yielded misleadingly low rates of user error. Such errors included spraying naloxone into the air rather than into the nostril of the person who overdosed and failing to wait the recommended two to three minutes between doses if the person remains unresponsive. Some of the company’s study groups also failed to include significant numbers of limited-literacy participants. However, the panel felt that the urgent need for overdose treatment amid the current opioid crisis outweighed these criticisms.

In December, the FDA accepted for priority review a New Drug Application (NDA) for Harm Reduction Therapeutics Inc.’s OTC RiVive (3.0 mg intranasal naloxone) for the emergency treatment of opioid overdose. The company submitted the NDA after the FDA encouraged pharmaceutical companies to develop new nonprescription naloxone products. Harm Reduction Therapeutic Inc. said that it expects to learn the FDA’s decision on approval by the end of April.

For related information, see the Psychiatric News articles “Naloxone Prescription Fills Inch Upward, But Remain Low Overall” and “Naloxone Costs Rise for Uninsured Patients.”

(Image: iStock/adisa)

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