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FDA Calls for OTC Naloxone Development

January 23, 2019
Agency paves way for greater access to the opioid overdose-reversal drug

A PPM Brief

FDA has announced1 the creation and testing of a product label to encourage development of an over the counter (OTC) version of naloxone. This takes the responsibility off of companies to create such labels and conduct studies to allow consumers to use naloxone without the help or supervisions of a healthcare professional. While FDA-approved versions of naloxone currently require a prescription, which may be a barrier for some, having naloxone widely available through an approved OTC product is “an important public health advance,” according to a statement made by FDA Commissioner Scott Gottlieb, MD.

FDA has, for the first time, developed a model Drug Fact Label (DFL) with easy-to-understand pictograms on how to use the drug, while conducting label comprehension testing to ensure the instructions are simple. A noted barrier, current FDA-approved prescription versions of naloxone do not have consumer-friendly DFLs, which are a requirement for OTC products. Before submitting a new drug application (NDA) for an OTC product, companies must develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a healthcare professional.

The agency has paved way for greater access to the opioid overdose-reversal drug. (Source: 123RF)

Model DFLs for two versions of naloxone (nasal spray [ie NARCAN] and auto-injector [ie Evzio]), and the supporting FDA review, “should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” according to the statement.

The model DFL was tested in a prespecified research design involving over 700 participants across a wide range of potential OTC naloxone users, including:

  • heroin users
  • prescription opioids users
  • family and friends of opioid users
  • adolescents
  • and the general public.

Overall, the study demonstrated that the model DFL was well understood by consumers and is acceptable for use by manufacturers in support of OTC naloxone development programs.

“We’re taking many steps to improve availability of naloxone products and we’re committed to working with other federal, state and local officials; healthcare providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction,” said Dr. Gottlieb.

Last updated on: February 1, 2019
Continue Reading:
Opioid Withdrawal: A New Look at Medication Options
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