FDA Issues Draft Guidance for Development of Non-Opioid Analgesics

The FDA recently issued draft guidance to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction.

The guidance provides recommendations to companies developing non-opioids analgesics for acute pain lasting up to 30 days, typically in response to some form of tissue injuries, such as trauma or surgery.

The guidance supports the HHS Overdose Prevention Strategy, which focuses on four priority areas: privacy prevention, harm reduction, evidence-based treatment, and recovery support.

“Opioid misuse and abuse remain a serious public health crisis facing the country. Preventing new addiction through fostering the development of novel non-opioid analgesics is an important priority for the FDA,” Patrizia Cavazzoni, MD, director of the FDA’s center for drug evaluation and research, said in the announcement.

“The guidance reinforces the agency’s commitment to confront opioid misuse, abuse and addiction by taking steps to help those with acute pain get access to improved non-opioid treatment alternatives,” Cavazzoni continued.

Opioid analgesics are a vital part of acute pain management, FDA stated. But they post a risk for addiction, misuse, abuse, or overdose that may result in death. Therefore, aA non-opioid analgesic for acute pain that eliminates or significantly reduces the need for an opioid could help to alleviate patient suffering while combating the risks associated with using an opioid.

The draft guidance describes three aspects of non-opioid analgesic drug development for acute pain, including necessary drug development programs to generate data that support an indication for managing acute pain.

The second aspect notes the potential use of claims in labeling regarding elimination or reduction of opioid use, the data needed to support those claims, and the potential use of FDA’s expedited programs to support the development program.

Additionally, the guidance fulfills specificcertain legal requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT Act.

The SUPPORT Act directs the agency to issue or update existing guidance to help address challenges to developing non-addictive medical products to manage pain.