Suztrigine for the treatment of adults with moderate-to-severe acute pain

Journavx (suzetrigine; Vertex Pharmaceuticals, Boston, MA) has received approval from the Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe acute pain. Journavx is an oral, non-opioid, selective inhibitor of Nav1.8, which is a voltage-gated sodium channel that plays a role in pain signaling in the peripheral nervous system. According to a statement from the FDA, Journavx represents the first approval in a new class of non-opioid medicines for pain management.

The approval is based on positive data from 2 phase 3 studies evaluating the safety and efficacy of Journavx treatment for acute pain after bunionectomy and abdominoplasty. The primary outcome measures were time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) and clinically meaningful reductions in pain from baseline at 48 hours, according to the Numeric Pain Rating Scale (NPRS).For participants who received bunionectomy, the least squares mean difference in SPID48 was 29.3 for Journavx vs placebo (95% CI, 14.0 to 44.6; P=.0002).
For abdominoplasty, the least squares mean difference was 48.4 for Journavx vs placebo (95% CI, 33.6 to 63.1; P<.0001).
Journavx was associated with more rapid onset to meaningful pain relief vs placebo, as defined by a ≥2-point reduction in NPRS from baseline.

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

In addition to pooled data from the bunionectomy and abdominoplasty studies, the safety profile for Journavx was supported by data from a single-arm phase 3 (NCT05661734) study in participants who received treatment for surgical and nonsurgical pain. The most common adverse events were itching, muscle spasms, increased levels of creatine phosphokinase in the blood, and rash. The medicine is contraindicated for concomitant use with strong CYP3A inhibitors.

https://practicalneurology.com/news/journavx-a-non-opioid-nav18-inhibitor-for-pain-management-approved-by-the-fda