FDA Approves Nonopioid Journavx for Acute Pain: Daily Dose

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On January 30, 2025, we reported on on the US FDA approval of suzetrigine (Journavx; Vertex Pharmaceuticals) 50 mg oral tablets for the management of moderate to severe acute pain.

The approval

The novel highly selective voltage-gated sodium channel (NaV1.8) inhibitor is an oral first-in-class analgesic and represents the first new approach to pain management in more than 20 years. The sodium channel Na_V1.8 is selectively expressed in peripheral neurons, including neurons of the dorsal-root ganglia that transmit nociceptive signals. Selective inhibition of Na_V1.8 has the potential to create a new class of pain signal inhibitors that provide effective pain relief and avoid the addictive potential of opioids.

The FDA approval is based on positive results from 2 phase 3 pivotal clinical trials in which suzetrigine was used to treat moderate to severe acute pain following bunionectomy and abdominoplasty surgeries. Each trial met its primary endpoints, resulting in a statistically significant improvement of the time-weighted sum of the pain intensity difference from 0 to 48 hours compared to placebo as well as a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale. Additional data was submitted from a phase 3 single-arm safety and effectiveness study. Investigators evaluated treatment with suzetrigine for up to 2 weeks across a variety of surgical and nonsurgical pain conditions and reported a favorable safety profile with no serious adverse events. The most common side effects of Journavx include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.

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