Vertex Reports Phase 2 Results for Suzetrigine in Painful Lumbosacral Radiculopathy Treatment

Vertex Pharmaceuticals has announced promising findings from its Phase 2 trial of suzetrigine, an oral NaV1.8 pain signal inhibitor, in treating patients with painful lumbosacral radiculopathy (LSR). This investigational drug showed a noteworthy reduction in pain levels, achieving the study's main goal.

The trial's primary endpoint focused on the change in weekly average leg pain intensity from the start, measured by the Numeric Pain Rating Scale (NPRS) over 12 weeks. Suzetrigine demonstrated a significant reduction in pain with a mean score decrease of 2.02 points. A placebo group also showed a reduction, with a mean decrease of 1.98 points. However, the study wasn't structured for direct statistical comparison between the two groups.

In addition to its efficacy, suzetrigine proved generally well tolerated. The occurrence of adverse events was lower in the suzetrigine group (22.9%) compared to the placebo group (32.4%). Most reported side effects were mild to moderate, and no severe adverse events were related to suzetrigine. Furthermore, no participants discontinued treatment due to adverse effects in the suzetrigine group.

Suzetrigine's potential in pain management has been underscored by these findings, alongside its favorable safety profile. Despite the lack of marked difference between suzetrigine and placebo groups, post-hoc analyses suggest high placebo responses may have influenced the outcomes. These insights will inform the design of future trials to better distinguish suzetrigine's effects from placebo responses.

Dr. Carmen Bozic from Vertex highlighted the consistent effect of suzetrigine across various pain conditions and its potential to address unmet needs in pain treatment. Christine Sang, a key investigator, emphasized the need to manage placebo responses in pain trials and anticipates advancements in clinical trial designs to confirm suzetrigine's efficacy in LSR.

Looking forward, Vertex intends to further develop suzetrigine for LSR in a Phase 3 study, pending regulatory discussions. The company is also pursuing a pivotal program for suzetrigine in painful diabetic peripheral neuropathy. Additionally, suzetrigine is under review by the FDA for treating moderate-to-severe acute pain, with a decision anticipated by January 2025.

Suzetrigine represents a new class of pain signal inhibitors targeting the NaV1.8 sodium channel, predominantly found in peripheral pain-sensing neurons. This approach seeks to provide effective pain relief without the drawbacks of existing treatments, such as opioid addiction risks.

Vertex continues to invest in developing new therapies across various serious diseases, with its ongoing efforts in acute and neuropathic pain research. The company remains committed to advancing innovative treatments to improve patient outcomes globally.