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Theravance to Present Analyses of Ampreloxetine and Neurogenic Orthostatic Hypotension at the 2025 International MSA Congress
DUBLIN, April 28, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that analyses of
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, April 28, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced that analyses of the initial Phase 3 program of ampreloxetine (Studies 169 and 170) will be presented at the International MSA Congress, taking place May 9-11, 2025, in Boston, Massachusetts. These analyses support the Company's understanding of ampreloxetine's highly selective mechanism of action and potential to address symptoms of neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). Results from these studies were supportive of a registrational study in patients with nOH and MSA that is currently ongoing (CYPRESS, NCT05696717).\n\n \n \n \n \n \n \n\n \nAnalyses will be presented in a plenary oral session Friday, May 9, and poster sessions Friday, May 9, 2025, and Saturday, May 10, 2025:\nAmpreloxetine in MSA: A pre-specified subgroup analysis of a phase 3, double-blind, placebo-controlled, randomized withdrawal trial\nNorcliffe-Kaufmann L, et al. Oral Presentation May 9, 2025 - 9:40 AM EDTNorcliffe-Kaufmann L, et al. Poster #78 May 10, 2025 - 12:00 PM EDTImpact of symptomatic neurogenic orthostatic hypotension on symptom burden and daily functioning in patients with alpha synucleinopathies\nIodice V, et al. Poster #29 May 9, 2025 - 11:45 AM EDTMore information on the session and abstracts may be found here.\nAbout ampreloxetine \nAmpreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.\nAbout CYPRESS (Study 0197), a Phase 3 Study\nStudy 0197 (NCT05696717) is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal st...