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news.Theravance Biopharma has received fast track designation from the US Food and Drug Administration (FDA) for TD-8954, a selective 5-HT4 receptor agonist, for short-term use with enteral feeding to achieve early nutritional adequacy in critically ill patients at high nutritional risk.
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TD-8954 is being evaluated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (EFI).
Currently, TD-8954 is in Phase II clinical development having most recently completed a study in critically ill patients with EFI to evaluate the safety, tolerability and pharmacodynamics of a single dose of TD-8954 administered intravenously compared to metoclopramide.
The company is preparing for further discussions with FDA regarding potential designs for the next TD-8954 study in EFI patients.
Theravance Biopharma Clinical Development senior vice-president Brett Haumann said: "This Fast Track designation provides key development and regulatory advantages to the TD-8954 program, adding important value to a product that we believe has significant potential to deliver therapeutic benefit to critically ill patients with gastrointestinal motility disorders, including EFI.
"This regulatory milestone comes at an opportune time for Theravance Biopharma as we continue to assess accelerated development pathways for this program through conversations with FDA, as well as potential collaboration with prospective partners.
"We look forward to making additional progress in these discussions and optimally positioning this novel therapeutic for success."