BRIEF—Vertex advances VX-548 in acute and neuropathic pain

Following the positive Phase II results earlier this year and having reached agreement on the design of the pivotal development program with the US Food and Drug Administration (FDA), Vertex Pharmaceuticals plans to advance the selective NaV1.8 inhibitor VX-548 into Phase III clinical trials in the fourth quarter of 2022.

Vertex also intends to initiate a Phase II 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.

Best known as a champion of treatments for cystic fibrosis, pain represents Vertex’ bid to go beyond its CF comfort zone. This is Vertex’ fourth attempt to develop a sodium channel Nav1.8 inhibitor, after VX-128, VX-150 and VX-961 failed to impress.