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FDA Tries to Speed OTC Naloxone Products

The FDA announced new efforts to expand naloxone access Thursday by making it easier for companies to make over-the-counter (OTC) versions of the opioid overdose treatment.

Naloxone is not yet available OTC, prompting the FDA to try streamlining the label-development process by proactively creating two Drug Fact Label (DFL) templates to support OTC nasal spray and injectable products. DFLs are the consumer-friendly instructions that must accompany OTC drugs. Normally, applicants seeking approval for OTC status propose and test the DFL. This is the first time the agency has created and tested DFLs itself, said FDA Commissioner Scott Gottlieb, MD.

“One of the key components for OTC availability is now in place,” he said in a statement. “In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.”

The agency also conducted label comprehension testing to ensure the instructions were simple to follow. Some companies have said the requirement to perform comprehension studies had been a barrier to developing OTC naloxone products, Gottlieb said.

The FDA labels contain pictures showing how to use naloxone nasal sprays and auto-injectors. Product-specific instructions are not included and have not been tested by the FDA; companies will have to tweak the labels before they can be used. “Apart from this product-specific information, the model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone,” Gottlieb said.

The FDA announcement follows a Department of Health and Human Services recommendation last month that naloxone should be prescribed with opioids for patients at risk for overdosing. Last year, the U.S. Surgeon General issued a public health advisory urging more Americans to carry and learn the drug. Most states allow naloxone to be sold without a prescription, but not all pharmacies carry it.