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Theravance Biopharma to Present New Ampreloxetine Data at the 34th International Symposium on The Autonomic Nervous System
DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that a new,
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society (AAS), taking place November 15-18, 2023, in Rio Grande, Puerto Rico. Anchor-based analyses help establish thresholds used to interpret the clinical meaningfulness of changes in patient-reported outcomes measures such as the Orthostatic Hypotension Questionnaire (OHQ).\n\n \n \n \n \n \n \n\n \n\"The results of this anchor-based analysis of prior ampreloxetine studies underscore the clinical relevance of the Orthostatic Hypotension Symptom Assessment domain of the Orthostatic Hypotension Questionnaire and further substantiate its use as a primary endpoint in clinical studies,\" said Horacio Kaufmann, M.D., Felicia B. Axelrod Professor of Dysautonomia Research, Department of Neurology at New York University School of Medicine. \"Those suffering from symptoms of nOH could benefit greatly from the availability of new therapies and identifying clinically meaningful changes in outcome measures is critical to bringing new medicines forward for nOH.\"1\nData will be presented in a poster session on Thursday, November 16, 2023, starting at 7:00 PM Atlantic Standard Time (3:00 PM PST / 6:00 PM EST / 11:00 PM GMT):\nKaufmann H, et al. Poster #95 Evaluating clinically meaningful changes in the Orthostatic Hypotension Symptom Assessment domain of the Orthostatic Hypotension Questionnaire\nData Presented at the 2023 AAS Annual Meeting:\nKey observations from this anchor-based analysis of the ampreloxetine Phase 3 studies, Study 0169 [SEQUOIA] and Study 0170 [REDWOOD], include the following:\nTwo measures of patient clinical status served as anchors to the Orthostatic Hypotension Symptom Assessment (OHSA) composite score for the analysis. Patient global assessment of change (PGI-C) at Week 4 served as an anchor in Study 0169 and patient global assessment of severity (PGI-S) at Week 6 of the randomized withdrawal period served as an anchor in Study 0170.The OHSA composite score was shown to correlate with both PGI-C and PGI-S, providing additional support for its use as an appr...