The US FDA has issued new draft guidance on ways to expand development of nonopioid treatment alternatives for patients with chronic pain as another strategy for fighting the continuing US opioid crisis.

The draft guidance outlines regulatory considerations, including study designs that ensure safety along with efficacy and “meaningful” outcomes, to help reduce misuse of prescription opioids.

“Physicians need more alternatives” for treating these patients, Marty Makary, MD, FDA commissioner, said in a release.

“FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain,” Makary added.

Once fully published, the document will fulfill a mandate requiring the FDA to issue guidance on ways to address challenges of developing nonopioid pain management treatments. 

The agency noted that approximately 1 in 5 US adults are still prescribed opioids for chronic pain. 

Broad Strategy

As previously reported by Medscape Medical News, the FDA announced last month that it is requiring opioid manufacturers to update safety labels in order to better warn about long-term use risks. 

Those changes are based on observations from a recent meeting between the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

The FDA noted in the current release that other parts of its strategy for addressing the opioid crisis include better enforcement surrounding the importing and sales of illegal opioid products and acting as a facilitator for the development of new nonopioid options — such as with the upcoming guidance.

Some of the points outlined in the draft guidance include establishing broader categories for covering multiple rather than individual chronic pain conditions; designing more robust clinical trials, such as with better outcomes and appropriate patient populations; and “evaluating the ability of nonopioid drugs to avoid, reduce, or eliminate opioid use.” 

“America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways,” Makary said.

The public is encouraged to comment on the draft guidance, which is titled “Development of Non-Opioid Analgesics for Chronic Pain” on the Federal Register’s website.