FDA Approves First Over-the-counter Naloxone (Narcan)

By Politico
Posted on 03/29/23 | News Source: Politico

The FDA on Wednesday approved Narcan, an opioid overdose reversal drug, to be sold without a prescription.

The approval marks the first time any form of naloxone will be available without a prescription. The drug, which first received FDA approval in 1971, was originally an injection. The FDA approved the inhaled nasal spray version, more commonly known as Narcan, in 2015. It contains 4 mg of naloxone that can be sprayed into the nose like a common allergy medication.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert Califf said in a statement.

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.