FDA Assigns Review Date for Non-Opioid Pain Medication

The FDA has accepted the new drug application (NDA) submission for suzetrigine to treat moderate-to-severe acute pain and granted priority review. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Jan. 30, 2025. Suzetrigine has already been granted Fast Track and Breakthrough Therapy designations.

Developed by Vertex Pharmaceuticals, suzetrigine is a new class of pain medicine. It targets a specific receptor, NaV1.8, that plays a role in pain signaling.

Scott Weiner, M.D.

“Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” Scott Weiner, M.D., M.P.H., Vertex Acute Pain Steering Committee Chair, associate professor of Emergency Medicine at Harvard Medical School and attending emergency Physician in the Department of Emergency Medicine at Brigham and Women’s Hospital, said in a news release.

The submission is based on data from two phase 3 studies, as well as a single arm safety and effectiveness study enrolled patients with a broad range of surgical and non-surgical pain.

In one study, the patients enrolled had received abdominoplasty surgery and the second study enrolled patients who had received bunionectomy surgery. In both studies, suzetrigine resulted in a statistically significant improvement on the primary endpoint of the time-weighted sum of the pain intensity difference in the first 48 hours compared with placebo, as well as a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale.

But both of these trials did not meet a key secondary endpoint when suzetrigine was compared with hydrocodone/acetaminophen.

In the three studies, the majority of adverse events were mild to moderate, and there were no serious adverse events related to suzetrigine. In the two studies, the incidence of adverse events was lower in the suzetrigine arm than the placebo arm.

These results were released in January 2024.

Suzetrigine is also being studied in other pain conditions. Vertex has begun a confirmatory phase 3 program of suzetrigine to treat patients with diabetic peripheral neuropathy, a type of nerve damage that results from diabetes. This program will include two identical 12-week placebo-controlled studies. The primary endpoint for both studies will be the change from baseline in weekly average of daily pain intensity on the Numeric Pain Rating Scale assessed at week 12 compared with placebo. Both studies will also include a secondary endpoint comparing suzetrigine with pregabalin.

About 1,100 patients are expected to enroll in each study, and patients will have the option to be included in the open-label study to evaluate the long-term safety and effectiveness.

Vertex released results from its phase 2 study in patients with diabetic peripheral neuropathy in December 2023. All suzetrigine treatment groups showed statistically significant and clinically meaningful reductions from baseline in pain measured by the Numeric Pain Rating Scale.

Vertex also is enrolling patients in a phase 2 study in patients with lumbosacral radiculopathy, which involves compression of the nerves in the lumbar spine.