Today, the U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. The agency issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain lasting up to 30 days, typically in response to some form of tissue injury, such as trauma or surgery. This guidance supports the HHS Overdose Prevention Strategy, which focuses on four priority areas — primary 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Prescribed appropriately, opioid analgesics are an important part of acute pain management. However, even at prescribed doses, they pose a risk for addiction, misuse, abuse or overdose that may result in death. A non-opioid analgesic for acute pain that completely eliminates or significantly reduces the need for an opioid could have a major public health impact by alleviating patient suffering from acute pain while mitigating the risks associated with using an opioid. This guidance may further spur development of these types of non-addictive treatment options to reduce the footprint of opioid use in this setting.
The draft guidance describes the agency’s current thinking about three aspects of non-opioid analgesic drug development for acute pain: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 the FDA’s expedited programs to support the development program.
The guidance also fulfills certain legal requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, commonly referred to as 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.
The FDA is accepting public comments on the draft guidance documents until April 11, 2022 so that the agency may consider comments before potentially issuing final guidance documents; however, comments on guidance documents are welcome at any time.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.