Vertex’s VX-548 Gets Breakthrough Therapy Designation for Acute Pain

Vertex Pharmaceuticals’ investigational oral drug VX-548 has received FDA’s Breakthrough Therapy designation for the treatment of patients with moderate-to-severe acute pain.

The investigational drug is an oral, selective inhibitor of the NaV1.8 sodium ion channel that plays a critical role in pain signaling in the peripheral nervous system.

Following positive phase 2 data, Vertex plans on advancing VX-548 into phase 3 clinical trials in the fourth quarter this year. The company also plans on launching a phase 2 dose-ranging study of VX-548 in neuropathic pain by the end of this year.

The FDA’s Breakthrough Therapy designation is meant to expedite the development and review of drugs that are intended to treat a serious condition. The designation requires preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies.