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Vertex Pharmaceuticals Announces Progress of Suzetrigine (VX-548) in Addressing Acute and Neuropathic Pain

Friday, April 19, 2024

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has unveiled significant progress in its suzetrigine pain program, potentially marking a breakthrough in acute and neuropathic pain treatment. Suzetrigine, an oral selective NaV1.8 pain signal inhibitor (formerly VX-548), has shown promise in Phase 3 trials for acute pain, leading to a rolling New Drug Application (NDA) submission to the FDA for moderate-to-severe acute pain. This submission, expected to conclude by the second quarter of 2024, follows previous FDA designations of Fast Track and Breakthrough Therapy for this indication.

In neuropathic pain, positive outcomes from a Phase 2 study in December 2023 and a successful end-of-phase 2 meeting with the FDA have propelled Vertex towards initiating a Phase 3 pivotal program targeting patients with diabetic peripheral neuropathy (DPN) in the latter half of 2024. Recently, the FDA granted Breakthrough Therapy designation for suzetrigine in treating DPN-associated pain.

The upcoming Phase 3 program will comprise two identical 12-week randomized, double-blind, placebo-controlled studies assessing suzetrigine's efficacy and safety in DPN patients. These studies will focus on key endpoints such as the change in weekly average daily pain intensity compared to both placebo and pregabalin. Approximately 1,100 patients are expected to enroll in each Phase 3 study, with opportunities for long-term safety and effectiveness evaluations in an open-label study post-randomized controlled trials.

Vertex is also actively enrolling participants in a Phase 2 study for suzetrigine in lumbosacral radiculopathy (LSR), slated for completion by year-end.

Dr. Carmen Bozic, Executive Vice President of Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex, emphasized the significance of these advancements in pain management, highlighting suzetrigine's promising benefit/risk profile across clinical trials and positive interactions with regulatory bodies.

Looking forward, Vertex remains committed to serial innovation in its pain portfolio, with plans to advance preclinical and clinical development of additional NaV1.8 and NaV1.7 pain signal inhibitors. This strategy aims to address the acute and neuropathic pain landscape comprehensively, potentially offering improved treatment options to millions of patients suffering from these conditions.

Acute pain, lasting less than 3 months, affects over 80 million individuals annually in the U.S., highlighting the urgent need for enhanced treatment options. Similarly, peripheral neuropathic pain encompasses various chronic conditions, including diabetic peripheral neuropathy and lumbosacral radiculopathy, collectively affecting an estimated 10 million patients annually in the U.S.

Suzetrigine (VX-548) stands out as an investigational oral medication with a highly selective mechanism targeting NaV1.8, a pivotal player in pain signaling within the peripheral nervous system. Its favorable benefit/risk profile, demonstrated across multiple clinical studies, underscores its potential as a non-opioid alternative for pain management.

By selectively inhibiting NaV1.8, Vertex aims to pioneer a new class of pain signal inhibitors capable of delivering effective pain relief without the limitations associated with current therapies, including the risk of addiction posed by opioids.



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