Beyond Opioids: FDA Approval of Suzetrigine Brings New Era in Pain Management

Credit: Business Wire

The U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ suzetrigine (Journavx) 50-milligram oral tablets for adults with moderate to severe short-term pain, such as after trauma or surgery. Unlike opioids, this first-in-class non-opioid analgesic works by blocking pain signals before they reach the brain.

Over 80 million Americans are treated with medication for moderate to severe acute pain, with about 40 million being prescribed opioids. However, nearly 10% of those initially given opioids continue using them long-term, and around 85,000 develop opioid use disorder each year. If not properly managed, acute pain can lead to chronic pain, lower quality of life and a greater strain on the health care system.

The FDA has been working to support non-opioid pain treatments as part of its effort to prevent opioid misuse through its FDA Overdose Prevention Framework.

“A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research.

Efficacy was assessed in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain after abdominoplasty and bunionectomy. During the trials, patients were able to use ibuprofen if needed. Results demonstrated statistically significant reductions in pain for those treated with suzetrigine compared with placebo.

Pooled, double-blind, placebo- and active-controlled trials supported the safety profile of the drug among 874 patients with moderate to severe acute pain following bunionectomy or abdominoplasty surgery. These findings were strengthened by an additional single-arm, open-label study of 256 patients with moderate to severe pain in a variety of conditions.

Common adverse events included itching, rash, muscle spasms and increased creatine phosphokinase.

“With the approval of Journavx, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” Reshma Kewalramani, M.D., chief executive officer and president of Vertex, said in a statement.