FDA Approves Nasal Naloxone For Over The Counter Use

Until recently, Narcan was only available with a prescription, but the Food and Drug Administration (FDA) has approved a specific naloxone product for use without a prescription: a four-milligram naloxone hydrochloride nasal spray.

Naloxone rapidly reverses the effects of an opioid overdose and is considered the standard treatment.

Lindsay Acree is the Pharmacist-In-Charge at the University of Charleston’s Patient Care Clinic, PharmUC, and an assistant professor in the pharmacy department.

“The motivation is that we’re seeing more and more overdoses,” Acree said. “You know, just because you don’t use a substance doesn’t mean that you don’t have a friend or a family member that doesn’t, so I think that it gives people the opportunity to have it with them, for individuals that they may encounter that have overdosed.”

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. As part of 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.

Still, some worry about the lack of training in using naloxone, but according to Acree, a helpful label will show how to use it.

“Anytime something goes over the counter, it has to be labeled in a way that anyone can understand it, basically,” Acree said. “I mean, it has to be regardless of their level of education, they have to be able to understand how to use it safely and effectively.”

Some advocates, like Amy Saunders, the managing director of Marshall University’s Center of Excellence for Recovery, worry about the unannounced cost of over-the-counter Naloxone nasal spray.

“I think it’s going to maybe make it more accessible to a lot of lot more different types of folks, and in a lot of different types of places and venues,” Saunders said. “But I think the price is going to be really important for us to kind of understand that piece.”

After the FDA’s announcement, Sen. Joe Manchin D-WV released a statement applauding the drug’s approval.

“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug related overdoses,” 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.