Vertex Announces FDA Acceptance of Suzetrigine NDA for Acute Pain
Vertex Pharmaceuticals today revealed that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for suzetrigine, an investigational oral NaV1.8 pain signal inhibitor designed to treat moderate-to-severe acute pain. This innovative drug has the potential to introduce the first new class of medicine for acute pain in over twenty years.
The FDA has granted suzetrigine priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. Suzetrigine has also received Fast Track and Breakthrough Therapy designations from the FDA for this indication.
“This acceptance of our NDA for suzetrigine is a significant step towards offering a new, non-opioid option for patients experiencing moderate-to-severe acute pain in the U.S.,” said Nia Tatsis, Ph.D., Executive Vice President and Chief Regulatory and Quality Officer at Vertex. “The priority review highlights the urgent need for alternatives to current pain treatments, bridging the gap between medications with limited efficacy and opioids with known risks.”
Scott Weiner, M.D., M.P.H., Chair of Vertex’s Acute Pain Steering Committee, and Associate Professor of Emergency Medicine at Harvard Medical School, added, “After 24 years in medicine, it’s clear that there is a critical need for new non-opioid therapies. Many patients are either inadequately treated or avoid pain relief due to concerns about opioid dependency. New options are essential.”
About Acute Pain
Acute pain, lasting less than three months, affects over 80 million people annually in the U.S. Due to limited treatment options, there is a significant unmet need to improve patient care and reduce the associated economic and societal impacts.
About Suzetrigine (VX-548)
Suzetrigine (formerly VX-548) is an investigational oral NaV1.8 pain signal inhibitor, specifically targeting the NaV1.8 channel in peripheral pain-sensing neurons. This channel is crucial for transmitting pain signals. Suzetrigine has shown a promising benefit/risk profile in multiple Phase 3 and Phase 2 studies, including those for diabetic peripheral neuropathy, a chronic pain condition. Vertex aims to provide effective pain relief without the limitations of current therapies, including opioid dependency.
About Vertex
Vertex Pharmaceuticals, founded in 1989 and headquartered in Boston with international offices in London, is a leading biotechnology company focused on developing transformative medicines for serious diseases. The company has approved treatments for cystic fibrosis, sickle cell disease, and beta thalassemia, and continues to explore therapies for various serious conditions. Vertex is recognized for its workplace excellence and ongoing commitment to scientific innovation.
Forward-Looking Statements
This release includes forward-looking statements as defined by the Private Securities Litigation Reform Act. These statements reflect the company’s current beliefs and are subject to risks and uncertainties. Actual results may differ due to various factors, including those discussed in Vertex’s annual and quarterly reports available on the SEC website and the company’s website. Vertex assumes no obligation to update these statements.
