Theravance Biopharma, initiates Phase III trial of TD 9855 to treat symptomatic neurogenic orthostatic hypotension.

Theravance Biopharma, Inc. announced dosing of the first patient in a registrational Phase III clinical trial of ampreloxetine (TD 9855) in patients with symptomatic neurogenic orthostatic hypotension (nOH). Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor (NRI) in development for the treatment of patients with symptomatic nOH.

The Phase III study is a four-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of ampreloxetine in approximately 188 patients with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson's disease (PD) and pure autonomic failure (PAF). Patients will be randomized to receive a single 10 mg dose of ampreloxetine or placebo once daily for four weeks. The primary endpoint of the study is change from baseline in dizziness severity, as measured by Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 (OHSA #1, a measure of dizziness, lightheadedness or the sensation of being about to black out) at four weeks for ampreloxetine as compared to placebo. The study will evaluate additional efficacy assessments, as well as safety and tolerability measures.