Dive Brief:

• The Food and Drug Administration on Wednesday issued draft recommendations for drugmakers interested in developing new non-opioid options to treat chronic pain. 
• The document lays out the agency’s expectations for clinical trials and includes recommendations for seeking broad indications for pain that cover multiple conditions instead of just one. It also details how drugmakers should test their experimental medicines to see if they can help patients reduce or replace opioids or avoid starting on the drugs altogether.
• Agency officials are open to offering expedited clearance pathways to spur the development of non-opioid medicines, according to the guidance. Still, the FDA warned that it may be difficult to use the accelerated approval program because pain is so personal that it’s “difficult to envision how surrogate or intermediate endpoints could be used to predict analgesic effect.”

Dive Insight:

While their addictive properties are now well known, opioids remain commonly prescribed because they are effective at neutralizing pain and often available in cheap, generic form. About one out of every five adults suffering from chronic pain takes opioids, according to the FDA. 

Efforts to develop alternatives have been hampered by the significant challenges in pain research. Scientists don’t fully understand the mechanisms behind pain and analgesia, and two people with the same injury can have completely different experiences. In addition, compounds that look promising in laboratories often fail to translate to safe and effective medicines for people.

The FDA is hoping to kickstart more research by making “regulatory pathways more predictable for innovators and drug developers,” with the guidance, FDA Commissioner Marty Makary said in a statement accompanying the guidance. “Physicians need more alternatives.”

There are signs of promise in the industry. Vertex Pharmaceuticals in January won approval for Journavx, a first-of-its-kind, non-opioid medicine to treat acute episodes of pain, often experienced after an accident or surgery. Several other biotechs are looking to develop similar treatments.

The FDA guidance should help spur more interest in the industry, Jefferies analyst Andrew Tsai said in a note to clients. “We sense a high degree of FDA interest in helping sponsors develop non-opioid approaches,” Tsai wrote. He said he expects companies, including Xenon Pharmaceuticals and Rapport Therapeutics, to consider exploring the FDA’s expedited pathways for review.

The agency issued the guidance to meet a requirement in the SUPPORT Act, a law designed to help patients and communities coping with the opioid crisis.