Vertex to run late-stage studies for pain therapy in 4Q 2022
designer491/iStock via Getty Images


Vertex Pharmaceuticals (NASDAQ:VRTX), a biotech specializing in treatments for cystic fibrosis, announced on Friday that the company reached an agreement with the FDA to start its late-stage program for the pain therapy VX-548 in 4Q 2022.

âWe are very pleased to complete our discussions with the FDA and reach agreement on the design of the pivotal development program for acute pain,â remarked Carmen Bozic, the Chief Medical Officer of Vertex (VRTX).
The Phase 3 trial, comprised of two randomized double-blind placebo-controlled studies, will be designed to evaluate the efficacy and safety of VX-548 for acute pain after bunionectomy or abdominoplasty surgeries.
In addition, Vertex (VRTX) intends to start a Phase 2 trial for VX-548 in neuropathic pain by the year-end. The double-blind, active-controlled, dose-ranging study will be designed to evaluate the therapy in patients with painful diabetic peripheral neuropathy.

The FDA has issued the Breakthrough Therapy Designation for VX-548 as a treatment for moderate-to-severe acute pain.
In March, Vertex (VRTX) announced positive Phase 2 data for the treatment of acute pain following abdominoplasty or bunionectomy.