The FDA has approved suzetrigine (Journavx, Vertex Pharmaceuticals) 50 mg oral tablets as a first-in-class nonopioid analgesic to treat all types of moderate-to-severe acute pain in adults.  

Suzetrigine reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. It is the first drug to be approved in this new class of pain management medicines.

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, JD, MD, the acting director of the FDA's Center for Drug Evaluation and Research. “A new nonopioid 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.”

The efficacy of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with suzetrigine compared to placebo.

The safety profile of suzetrigine is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate-to-severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate-to-severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received suzetrigine were itching, muscle spasms, increased blood level of creatine phosphokinase and rash. Suzetrigine is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking the drug.

—Clinical Oncology News Staff

Based on a press release from the FDA.