FDA approves first over-the-counter Narcan

Emergent BioSolutions, which makes the drug, estimates that it would begin commercializing OTC Narcan by late summer.

“We have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” Emergent’s president and CEO Robert Kramer said in a statement.

The members of the FDA’s Nonprescription Drugs Advisory Committee and the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously in February to recommend the agency approve Emergent BioSolution’s bid for over-the-counter Narcan.

Narcan’s approval without a prescription marks a win for the Biden administration, which has been combating the opioid overdose crisis. In 2021, opioid overdoses killed more than 81,000 people, up nearly 20 percent from the prior year. Late last year, the administration put out a notice detailing the information the FDA would require to consider approving certain versions of naloxone without a prescription, including Narcan.

Public health experts, including the FDA’s advisers, said removing the prescription requirement from Narcan would improve access to the life-saving drug. Even though all 50 states and the District of Columbia allow pharmacists to prescribe the drug directly to patients or allow patients to receive the drug through harm-reduction programs like safe syringe exchanges, naloxone is still not widely accessible.

A two-pack of Narcan with 4 mg each costs about $70. It’s not clear whether Emergent BioSolutions will continue to sell the drug at that cost, and a company spokesperson was not able to provide an OTC price when asked.

“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” Califf said in a statement.

What’s next: The FDA is still considering an application from Harm Reduction Therapeutics for its naloxone nasal spray. The agency canceled a meeting of the two advisory committees it had scheduled to discuss the application earlier this month, saying that the committees’ discussion of Narcan answered similar questions about HRT’s product.