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Theravance Biopharma Completes Enrollment in Pivotal Phase 3 CYPRESS Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension due to Multiple System Atrophy
Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission If approved, ampreloxetine could address a critical unmet
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA)Ampreloxetine has Orphan Drug Designation in the U.S., underscoring the unmet need in symptomatic nOH due to MSADUBLIN, Aug. 25, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH), today announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder. nOH is a devastating condition affecting approximately 80% of MSA patients and is characterized by sudden drops in blood pressure upon standing, leading to symptoms such as dizziness, fainting, and blurry vision. These symptoms can lead to serious consequences, including falls, disability, and loss of independence. Despite its severity and impact, there is a lack of effective and durable treatment options that are specifically designed to treat nOH in patients with MSA.\n\n \n \n \n \n \n \n\n \n\"nOH is one of the most debilitating manifestations of MSA, which affects about 40,000 patients in the U.S. alone. Yet current therapies often fail to provide lasting symptoms relief, require frequent dosing and carry a boxed warning for supine hypertension,\" said Dr. Horacio Kaufmann, F. B. Axelrod Professor of Neurology and Professor of Medicine at NYU Grossman School of Medicine. \"Ampreloxetine is designed to address the underlying cause of nOH. In Study 0170, it showed compelling improvement in OHSA composite score without worsening supine hypertension.1 If these benefits are confirmed, I would expect to use ampreloxetine in the majority of my patients living with nOH due to MSA. I am encouraged that enrollment in CYPRESS, the first randomized-withdrawal trial designed specifically for the MSA population, has been completed, and I look forward to seeing the data early next year.\"\nThe registration-enabling Phase 3 CYPRESS (NCT05696717) study is a global, randomized-withdrawal s...