Manchin Applauds FDA Approval of First Over-The-Counter Naloxone

Washington, DC – Today, U.S. Senator Joe Manchin (D-WV) applauded the U.S. Food and Drug Administration’s (FDA) approval of Narcan as the first over-the-counter (OTC) naloxone hydrochloride nasal spray. Naloxone is a life-saving medication that rapidly reverses the effects of an opioid overdose and today’s decision paves the way for it to be sold directly to consumers in places like drug stores, convenience stores and grocery stores.

 

“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug related overdoses,” Senator Manchin said. “Given the enormous scale of need, it has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale. Naloxone is an immeasurably valuable resource for our fight against the drug epidemic, and it is proven to be safe and effective for public use. I’m thrilled to see the FDA take this meaningful action to make naloxone available over-the-counter, which helps reduce stigma and encourages the widespread use of this critical medication during emergencies. Today’s decision is a huge step in the right direction to make affordable Narcan accessible for every West Virginian and American, and it will save lives.”

 

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with the 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 without the supervision of a healthcare professional.

 

On April 12^th, 2022, Senator Manchin led a bipartisan, bicameral effort to make Naloxone available over the counter. On March 22^nd, 2023, Senators Manchin and Mike Braun (R-IN) wrote a letter to FDA Commissioner Robert Califf urging the agency to swiftly approve the sale of OTC naloxone.