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Vertex drug cuts pain in mid-stage trial, gets US FDA breakthrough tag

Boston's Vertex Pharmaceuticals Inc. said VX-150 delivered statistically significant and clinically meaningful pain reduction in a mid-stage study, meeting its main goal.

The six-week phase 2 trial enrolled patients with small fiber neuropathy, a condition in which narrow nerve fibers outside the brain and spinal cord are damaged, causing pain, burning and tingling.

Vertex said 46 patients received VX-150 and 43 patients received placebo, 91% and 81% of whom completed treatment, respectively.

The study measured patients' daily pain intensity on an 11-point scale and computed their weekly average: 6.43 in the VX-150 group and 5.99 in the placebo group. After six weeks of treatment, VX-150 reduced the rating by 2.02, while placebo only reduced it by 0.93.

Additionally, VX-150 was generally well-tolerated in the trial. Adverse events in the study were mostly mild or moderate, occurring in 63% of the VX-150 group and in 56% of the placebo group, according to Vertex.

The trial is Vertex's third positive proof-of-concept study for VX-150, the other two being for chronic pain due to osteoarthritis, and after bunionectomy surgery, which is still ongoing.

Separately, the U.S. Food and Drug Administration granted VX-150 breakthrough-therapy status for moderate to severe acute pain. The designation expedites the development and review of drugs meant to treat serious conditions.

VX-150 inhibits the NaV1.8 protein, which is found in certain neurons, to block signals of pain.