FDA takes big step toward over-the-counter naloxone

In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment.

A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, the agency wanted to create “model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access,” according to FDA chief Dr. Scott Gottlieb.

The U.S. regulatory body posted two model DFLs yesterday – one for use with a nasal spray and one for use with an auto-injector.

The models were tested by an independent research contractor, according to the FDA, with more than 700 participants across an array of potential OTC naloxone users, including people who use heroin and prescription opioids.

“Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on final label comprehension testing of how well consumers understand the product-specific information that hasn’t been already tested in the model DFL,” Gottlieb said.

“I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible,” he added.

Gottlieb has made tackling the opioid epidemic a priority during his tenure at the FDA. The number of overdose deaths involving opioids reached nearly 48,000 in 2017, according to the FDA chief.

He acknowledged that long-term medical attention for someone suffering from an opioid overdose is ideal, but immediate treatment with naloxone can be life-saving.

“Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we’ve been working on at the FDA,” he wrote.

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