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Vanda Pharmaceuticals Trial for Anxiety Drug Fails Primary Goal

A Phase 3 clinical trial of VQW-765 has collapsed, failing to demonstrate a statistically significant reduction in social anxiety among participants. The drug, intended to treat performance-related distress, showed no meaningful improvement over a placebo during testing, forcing the company to place the entire development program on indefinite hold.

Vanda Pharmaceuticals Trial for Anxiety Drug Fails Primary Goal

The trial centered on the Trier Social Stress Test, a rigorous assessment where subjects rate their nervousness on a 0 to 100 scale. Researchers focused on the distress levels experienced during the performance phase, but women treated with VQW-765 reported outcomes indistinguishable from those in the control group. The study also missed its key secondary endpoint, which evaluated the drug's efficacy across a broader cohort of 546 adult men and women.

This failure marks a significant setback for Vanda Pharmaceuticals, as the study was intended to validate promising results from an earlier Phase 2 trial. In that preliminary study, participants with a history of performance anxiety had reported lower stress levels while using the drug. With the current trial encompassing 30 sites, the company has opted to halt the project while experts conduct a deep analysis of the full dataset to determine if any viable path forward remains.

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