FDA aims to develop nonaddictive alternative to opioids

FDA issued draft guidance about its plan to develop nonopioid analgesics for acute pain in an effort to spur the development of nonaddictive alternatives.

The guidance defines acute pain as lasting up to 30 days, often the result of tissue injury such as trauma or surgery.

“Opioid misuse and abuse remain a serious public health crisis facing the country,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research. “Preventing new addiction through fostering the development of novel nonopioid analgesics is an important priority for the FDA.”

The draft guidance focuses on FDA’s current thinking about 3 facets of nonopioid analgesic drug development for acute pain: types of drug development programs that may be appropriate to generate data needed to support an indication for the management of acute pain, potential use of claims in labeling regarding the elimination or reduction of opioid use and the data needed to support those claims, and potential use of FDA’s expedited programs to spur the development program.

The guidance also supports the HHS Overdose Prevention Strategy, which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.

FDA is accepting comments on the draft guidance until April 11, 2022.