BOSTON– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that following the positive Phase 2 results earlier this year and having reached agreement on the design of the pivotal development program with the U.S. Food and Drug Administration (FDA), Vertex plans to advance the selective NaV1.8 inhibitor VX-548 into Phase 3 clinical trials in the fourth quarter of 2022. Vertex also intends to initiate a Phase 2 dose-ranging study of VX-548 in neuropathic pain by the end of this year. In addition, the FDA has granted VX-548 Breakthrough Therapy Designation for the treatment of moderate-to-severe acute pain.
The Phase 3 program will include two randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VX-548 for moderate to severe acute pain following bunionectomy or abdominoplasty surgery. Both studies will also include a hydrocodone bitartrate/acetaminophen treatment arm. A third, single-arm study will evaluate the safety and effectiveness of VX-548 for up to 14 days across multiple other types of moderate to severe acute pain.
“We are very pleased to complete our discussions with the FDA and reach agreement on the design of the pivotal development program for acute pain,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “VX-548 has demonstrated a positive benefit-risk profile in Phase 2 and we are working with urgency to bring forward a medicine that delivers effective pain control without addictive potential to patients who are waiting.”
