FDA Accepts Vertex's Suzetrigine Application for Acute Pain Treatment

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor, intended to treat moderate-to-severe acute pain. Suzetrigine could potentially be the first new class of medicine for acute pain in over twenty years.

The FDA has granted suzetrigine priority review status and set a Prescription Drug User Fee Act (PDUFA) target action date for January 30, 2025. The drug has already received Fast Track and Breakthrough Therapy designations from the FDA for treating moderate-to-severe acute pain.

Nia Tatsis, Ph.D., Executive Vice President, Chief Regulatory and Quality Officer at Vertex, commented that the FDA’s acceptance of the application for suzetrigine is a significant milestone. She emphasized that this new, non-opioid analgesic could greatly benefit millions of patients in the U.S. who suffer from moderate-to-severe acute pain each year. The priority review status underscores the urgent need for improved acute pain treatments, bridging the gap between existing medications that have good tolerability but limited efficacy and opioid therapies that, while effective, carry risks such as addiction.

Scott Weiner, M.D., M.P.H., Vertex Acute Pain Steering Committee Chair and Associate Professor of Emergency Medicine at Harvard Medical School, also spoke on the issue. With over two decades in medical practice, Dr. Weiner highlighted the critical need for new non-opioid pain therapies, noting that many patients are either inadequately treated, suffering side effects from current treatments, or avoiding pain medications altogether due to fear of opioid dependency. He stated that both prescribers and patients deserve new options for pain management.

Acute pain, defined as pain lasting less than three months, affects over 80 million people annually in the U.S., who are prescribed medicine for this condition. The limited treatment options available today necessitate the development of better solutions to enhance patient outcomes and alleviate the broader economic and societal impacts.

Suzetrigine (VX-548) is an investigational, oral, selective NaV1.8 pain signal inhibitor, selectively targeting the NaV1.8 voltage-gated sodium channel, which is specifically expressed in peripheral pain-sensing neurons (nociceptors). These neurons transmit pain signals, and NaV1.8 has been genetically validated as a target for pain treatment. Suzetrigine has shown a good benefit/risk profile in several Phase 3 and Phase 2 studies involving patients with moderate-to-severe acute pain. Additionally, it demonstrated positive and well-tolerated results in a Phase 2 study involving patients with pain associated with diabetic peripheral neuropathy, a form of chronic peripheral neuropathic pain. Vertex aims to selectively inhibit NaV1.8 using small molecules to create a new class of pain signal inhibitors that provide effective pain relief without the limitations of current therapies, including the risk of addiction linked to opioids.

Vertex is a global biotechnology company focused on scientific innovation to develop transformative medicines for serious diseases. The company has produced several approved medicines targeting the underlying causes of chronic, life-shortening genetic disorders such as cystic fibrosis, sickle cell disease, and transfusion-dependent beta-thalassemia. Vertex continues to advance clinical and research programs in these areas and has a robust pipeline of investigational therapies for other serious conditions, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1, and alpha-1 antitrypsin deficiency.

Founded in 1989 and headquartered in Boston, Vertex also maintains international headquarters in London, with research, development sites, and commercial offices globally. The company is consistently recognized as a top workplace in the industry.

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