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www.fdanews.com/articles/207297-theravances-investigational-drug-ampreloxetine-fails-second-phase-3-trial

Theravance’s Investigational Drug Ampreloxetine Fails Second Phase 3 Trial

April 7, 2022

Theravance Biopharma said that its investigational drug ampreloxetine failed its second phase 3 study in patients with symptomatic neurogenic orthostatic hypotension, a condition that frequently involves symptoms such as dizziness when standing up or changing position.

The clinical trial enrolled 128 participants with Parkinson’s disease, pure autonomic failure and multiple system atrophy. The study failed to achieve its primary endpoint of improvement in hypotension symptoms. An earlier phase 3 study had also failed to show a significant improvement in symptoms.

Despite the disappointing results, Theravance is still investigating the drug as a potential treatment for patients with multiple system atrophy, who showed the most benefit from the drug in the second phase 3 trial.

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