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# Breakthrough Designation for Vertex Pain Drug
- URL: https://www.fdaweb.com/breakthrough-designation-for-vertex-pain-drug/
- Published: 2022-07-27T12:00:00.000Z
- Updated: 2026-09-14T17:53:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152382

FDA has granted breakthrough therapy designation to Vertex Pharmaceuticals’ VX-548 to treat acute and neuropathic pain. The company [says](https://news.vrtx.com/news-releases/news-release-details/vertex-advances-vx-548-acute-and-neuropathic-pain?ref=fdaweb.com) it has reached agreement with FDA on the design of a pivotal Phase 3 trial that will open in the fourth quarter of this year. The Phase 3 program will include two studies evaluating the efficacy and safety of VX-548 for moderate-to-severe acute pain following bunionectomy or abdominoplasty surgery.