The FDA Issues Draft Guidance for Non-Opioid Chronic Pain Products – It Has Been an Arduous Quest for Industry!

The opioid crisis continues, and the battle of addiction remains ongoing as well. The FDA has approved one new non-opioid pain reliever (Journavx (suzetrigine tablets)) for moderate to severe acute pain in adults. The application holder UC Health claims (here) “[T]his new oral painkiller — the first approved by the FDA in more than 20 years — could offer an alternative to highly addictive opioids”.

But what about patients with chronic pain? The industry has been trying for decades to break the code on developing an effective non-addictive, non-opioid chronic pain medication. Now the FDA has laid out a blueprint in its newly released draft guidance titled Development of Non-Opioid Analgesics for Chronic Pain: Guidance for Industry which can be found here.

According to the Federal Register notice (here ) that announced the document, the FDA says, “[T]his guidance also responds to the statutory requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non-opioid medical products to treat pain”.

The guidance provides a nice background regarding the types of drugs that are currently being used for pain treatment and their mechanisms of action. The guidance discusses various clinical trial design considerations and notes the types of pain models and root causes of different types of pain that are necessary to be considered. It also discusses certain effectiveness considerations, evaluating avoidance, elimination, or reduction of opioid use, safety considerations, statistical considerations, and potential expedited program that may be available for development.

As the search for non-opioid chronic pain treatments continues, the strategies outlined in the Agency draft guidance hopefully will enlighten the industry in its quest for the pathway for approving a non-addictive pain relief product to treat chronic pain. It is certainly likely to open discussion between industry and the Agency. Remember, this guidance focuses only on chronic pain and not acute pain. Will it kickstart a discovery path for the holy grail of a non-opioid treatment for chronic pain relief? Only time will tell!