Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) has announced the initiation of a rolling new drug application (NDA) submission for suzetrigine (formerly known as VX-548) with the FDA. Suzetrigine, an investigational orally administered selective NaV1.8 pain signal inhibitor, is intended for the management of moderate-to-severe acute pain. The company aims to complete the NDA submission process by the second quarter of 2024.
The rolling NDA submission is backed by promising results from Vertex’s phase III program for suzetrigine in acute pain management. In January 2024, the company reported meeting primary endpoints in three phase III studies evaluating suzetrigine for treating moderate-to-severe acute pain. These late-stage studies included two pivotal phase III acute pain trials following bunionectomy surgery and abdominoplasty surgery, respectively, along with a 14-day single-arm phase III study across various surgical and non-surgical acute pain conditions.
Results from these studies demonstrated a significant reduction in pain intensity across a spectrum of pain conditions, both surgical and non-surgical, and in diverse settings. Suzetrigine has received Fast Track and Breakthrough Therapy designations from the FDA for the treatment of moderate-to-severe acute pain.
In addition to progress in the acute pain indication, Vertex has provided updates on the suzetrigine developmental program for neuropathic pain. Positive data from a mid-stage study on VX-548 in painful diabetic peripheral neuropathy (DPN) were reported in December 2023. This form of peripheral neuropathic pain showed a statistically significant and clinically meaningful reduction in pain intensity with suzetrigine treatment.
Following discussions with the FDA post phase II data readout, Vertex is preparing to initiate a pivotal phase III program of suzetrigine in patients with DPN in the second half of 2024. Suzetrigine also holds a Breakthrough Therapy designation from the FDA for the treatment of pain associated with DPN.
Despite a 3.3% decline in shares year to date, Vertex is optimistic about its planned pivotal late-stage program for suzetrigine. The program will consist of two identical 12-week randomized studies, each enrolling approximately 1,100 DPN patients. These studies will evaluate the efficacy and safety of suzetrigine (70 mg once daily) compared with placebo, with Pfizer’s Lyrica (pregabalin) serving as a reference.
Moreover, patients completing the treatment course with suzetrigine in the late-stage pivotal studies will have the option to enroll in an open-label study to assess the long-term safety and effectiveness of suzetrigine in DPN. Additionally, Vertex is conducting a phase II study on suzetrigine in patients with painful lumbosacral radiculopathy, another form of peripheral neuropathic pain, with enrollment expected to be completed by the end of 2024.
Vertex Pharmaceuticals is optimistic about the potential of VX-548 to revolutionize the standard of care for neuropathic pain, an area with limited treatment options, predominantly opioid-based medications. Besides the clinical program for suzetrigine, Vertex is also advancing several other preclinical and clinical NaV1.8 and NaV1.7 pain signal inhibitors, either as monotherapy or in combination, for treating acute and neuropathic pain.
The company is preparing to initiate phase II studies on its next-generation NaV1.8 pain signal inhibitor, VX-993 oral formulation, for acute pain and peripheral neuropathic pain later in 2024. Additionally, Vertex expects to commence a phase I study of an intravenous formulation of VX-993 in 2024.
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