Vertex Pharmaceuticals Offers Hope with Non-Addictive Acute Pain Management
Vertex Pharmaceuticals (Nasdaq: VRTX) is offering hope to the 80 million Americans suffering with acute pain each year with a non-addictive pain management alternative. Today, the company announced positive results from its Phase 3 program for VX-548 in the treatment of moderate-to-severe acute pain.
Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline, and was safe and well tolerated.
Vertex plans to submit a New Drug Application to the FDA by mid-2024 with the goal of achieving a broad label in moderate-to-severe acute pain.
Commenting on the positive results, Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex, said, “”We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings. The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.
“With FDA Breakthrough and Fast Track Designations in hand, we are working with urgency to file the New Drug Application for VX-548 and bring this non-opioid medicine to the millions of patients who suffer from acute pain each year in the U.S.”
Highlights
Vertex’s Phase 3 program included two randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study which enrolled patients with a broad range of surgical and non-surgical pain conditions.
VX-548 has secured Breakthrough Therapy and Fast Track designations in the U.S. for acute pain.
Vertex is also seeking to achieve a broad label in peripheral neuropathic pain and recently reported positive Phase 2 results in painful diabetic peripheral neuropathy (DPN).
Acute pain is a disabling condition that affects over 80 million people in the U.S. each year. Due to limited treatment options, there is an unmet need in acute pain management to improve the patient experience and reduce the economic and societal burden.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 14 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and Twitter/X.
