Prnewswire·2025-04-28 10:00Core Insights - Theravance Biopharma announced the presentation of analyses from the initial Phase 3 program of ampreloxetine at the International MSA Congress, highlighting its potential to address neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][2] - The ongoing registrational study (CYPRESS) aims to evaluate the efficacy and durability of ampreloxetine in treating symptomatic nOH in MSA patients [4][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, with ampreloxetine being a late-stage investigational norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][10] - The company has received Orphan Drug Designation for ampreloxetine in the US, indicating its commitment to addressing unmet medical needs in rare diseases [3] Clinical Study Details - The CYPRESS study is a multi-center, randomized withdrawal trial evaluating ampreloxetine's efficacy after 20 weeks of treatment, with the primary endpoint being the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 0169 and Study 0170) assessed the efficacy and safety of ampreloxetine, with Study 0170 showing a significant benefit in MSA patients, indicated by a 72% reduction in treatment failure odds compared to placebo [5][7] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the US, of which 70-90% experience nOH symptoms [8][9] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [9]