FDA OKs First-In-Class Nonopioid Pain Med Suzetrigine

The US Food and Drug Administration (FDA) has approved suzetrigine 50 mg tablets (Journavx, Vertex Pharmaceuticals), a first-in-class nonopioid analgesic for treatment of adults with moderate-to-severe acute pain. 

Suzetrigine selectively inhibits the NaV1.8 pain-signaling pathway in the peripheral nervous system, a validated target for peripheral pain management.

Because suzetrigine blocks pain signals found only in the periphery, not in the brain, it provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids, the company said in a statement. 

The FDA granted suzetrigine priority review, fast-track, and breakthrough designations. The drug comes in 50-mg tablets and is approved for twice-daily use. 

The approval of suzetrigine is “an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA Center for Drug Evaluation and Research, said in a statement. 

“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. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” said Corrigan-Curay. 

Suzetrigine was evaluated in two phase 3 randomized, double-blind, placebo-controlled trials — one involving 303 adults who had abdominoplasty and one involving 274 adults who had bunionectomy. In both trials, ibuprofen was allowed when needed as rescue pain medication. 

Both trials showed rapid and statistically significant superior reduction in pain with suzetrigine compared with placebo. 

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

Full prescribing information is available online. 

The wholesale acquisition cost for suzetrigine in the United States is $15.50 per 50-mg pill, the company said.