Press release
United Therapeutics to Present Tyvaso DPI™ BREEZE Clinical Data at the European Respiratory Society International Congress 2021
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 24, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced it will
About this update from United Therapeutics Corporation
[{"type":"text","content":"SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 24, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced it will present data from a clinical trial studying Tyvaso DPI™ (treprostinil) in patients with pulmonary arterial hypertension (PAH) at the European Respiratory Society (ERS) International Congress 2021, which will be held virtually from September 5-8, 2021. \nData from the BREEZE study of Tyvaso DPI, a dry powder inhaled formulation of treprostinil, will be presented in a poster session on September 6, 2021. The BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso® Inhalation Solution who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. \nThe primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Top line data showing the BREEZE study met its primary objective were released in January 2021.\nSecondary objectives highlighted at the congress will include: (1) change in six-minute walk distance (6MWD); (2) patient satisfaction with and preference for inhaled treprostinil devices; and (3) patient-reported PAH symptoms and impact (PAH-SYMPACT®). Each objective was assessed at study entry when patients were using Tyvaso Inhalation Solution and after three weeks using Tyvaso DPI.\nAdditional pharmacokinetic (PK) data from the BREEZE and healthy volunteer studies will be presented at future medical congresses. \n\"We look forward to presenting important new data that serve as the basis of our pending New Drug Application for Tyvaso DPI,\" said Leigh Peterson, Ph.D., Senior Vice President, Product Development, at United Therapeutics. \"If approved by the FDA, Tyvaso DPI will provide a more convenient formulation of inhaled treprostinil that may increase prostacyclin accessibility.\" \nDetails for the poster presentation at ERS 2021 are as follows: \nTitle: BREEZE: Open-label, Clinical Study to Evaluate the Safety and Tolerability of a Treprostinil Dry Powder inhaler in Patients with Pulmonary Arterial Hypertension Currently using TyvasoLead Author: Leslie Spikes, M.D.\nThe poster will be available on the United Therapeutics Pipeline website following the conclusion of the congress. \nAbout PAH\nAlso known as World Health Orga...