August 15, 2016
2 min read

FDA voices support for expanded access to naloxone for opioid overdose

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The FDA is seeking ways to increase access to naloxone, a medication that can stop or reverse the effects of an opioid overdose, including assisting manufacturers in submitting applications for over-the-counter versions of the currently prescription-only emergency treatment.

In a statement published by the administration’s FDA Voice blog, Karen Mahoney, MD, deputy director of the FDA Division of Nonprescription Drug Products, said officials are working to facilitate the process of helping manufacturers gain approval for an OTC version of naloxone. To this end, the FDA has created a model Drug Facts Label for such a product, which it is currently testing.

“Overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine, and illicit opioids such as heroin and illegally produced fentanyl, have more than tripled since 1999, with about 28,000 people dying in 2014 alone,” Mahoney wrote. “Many of these tragedies could have been avoided if the people experiencing the overdose had immediately received the prescription drug naloxone, a life-saving medication that can stop or reverse the effects of an opioid overdose.”

According to Mahoney, there are two prescription naloxone products currently available — an auto-injector and a nasal spray formulation — and neither have the consumer-friendly Drug Fact Label required by law for any OTC medication.

The model label created by the FDA includes a simple pictogram that could be placed adjacent to the printed directions as a visual aid. Together, the label and pictogram are intended to provide consumers with the information needed to understand how to safely use the product, and when to use it, Mahoney said.

In addition, the FDA has arranged for the model label to be tested for consumer comprehension. According to Mahoney, manufacturers will be able to use the study findings to better focus their own final label comprehension testing.

“Creating a model [drug fact label] and arranging for label comprehension testing are among the ways that the FDA is working to fulfill our commitment to enhanced naloxone access, where possible, in our opioids action plan,” Mahoney said. “We will continue to work with interested manufacturers and developers to further explore the best uses of naloxone for the emergency treatment of known or suspected opioid overdoses until emergency medical help arrives.”

The FDA’s latest efforts with naloxone are part of a larger effort to curtail opioid overdoses, first announced by HHS in March 2015. The initiative has so far focused on improving the practices surrounding opioid prescribing, expanding access to medications that treat opioid use disorders, and increasing the use of naloxone to reverse the effects of opioid overdoses.

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