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FDA outlines plans for new guidance on developing pain drugs

August 30, 2018

By Jennifer Garvin

Silver Spring, Md. — The Food and Drug Administration said Aug. 29 that it intends to withdraw its existing analgesic guidance for developing new pain drugs and will issue new guidance in 2019.

The decision, said FDA Commissioner Scott Gottlieb, M.D., is in response to the shifting nature of the nation’s opioid epidemic. In prepared remarks, he noted that previously the crisis was “largely dominated” by prescription drug addiction but has now moved to one that “increasingly implicates the use of illicit drugs, including highly potent fentanyls. These drugs are obtained illegally, often through purchases made on-line, and in many cases shipped through the international mail.”

In withdrawing the FDA’s existing 2014 analgesic guidance, Dr. Gottlieb said the agency plans to issue no fewer than four documents, which will be released from February to August 2019. The documents are expected to broaden the range of new pain drug development opportunities and also help manufacturers market more efficiently. 

The new guidance documents will explore the following:

  • Nonopioid alternatives. This guidance “will set forth the FDA’s current thinking on how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications when used for acute pain,” Dr. Gottlieb said.
  • Charging drug makers with assessing the benefits and risks when new opioid pain drugs are put into development. “This will include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs.”
  • Developing extended-release local anesthetics, which can serve as an alternative to the systemic use of oral opioid drugs. “This guidance will address the clinical pharmacology, the proper evaluation of safety and efficacy, and the types of studies that may support approval of these products.”
  • Assisting sponsors with the development of new nonopioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids.

Dr. Gottlieb also detailed a recent FDA analysis that found declines in outpatient settings opioid dispensing.

He shared that in the first half of 2018, the volume of opioid analgesics dispensed was down more than 16 percent — going from 88.8 metric tons of oral morphine equivalent to 74.1 metric tons. The volumes of opioid analgesics dispensed in the first halves of 2017 and 2016 were also down.

“These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs,” he concluded.

Follow the ADA’s opioids advocacy efforts at