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PAH/PH Treatments: Macitentan (Opsumit™)

Author: Shelley Ensz. Scleroderma is highly variable. See Types of Scleroderma. Read Disclaimer
Overview Patient Stories

Overview

Macitentan (Opsumit) is a novel oral dual endothelin receptor antagonist for pulmonary hypertension. Actelion submitted its FDA new drug application for macitentan in October 2012.

Bosentan and macitentan (ERA's) prevent the endothelial–to–mesenchymal transition (EndoMT) in systemic sclerosis: in vitro study. The present study provides further in vitro evidence of the use of ERA in inhibiting the EndoMT process, supporting the clinical efficacy of these drugs in SSc therapy and their usefulness for interfering with progressive fibrosis. PMC, Arthritis Res Ther, October 2016; 18: 228. (Also see Tracleer (Bosentan) and Fibroblasts)

Actelion’s Opsumit™ Approved by FDA for Pulmonary Arterial Hypertension. The FDA has approved the use of Opsumit (Macitentan) for treatment of pulmonary arterial hypertension (PAH). The Guardian. 10/20/2013.

Actelion says FDA accepts Macitentan for review. Actelion has submitted an FDA application for macitentan for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by abnormally high blood pressure in the arteries of the lungs. The review is expected to take 12 months. Reuters. 12/14/12. (Also see Pulmonary Hypertension)

Phase III PAH outcome study with macitentan (Opsumit™) presented at CHEST - Significant reduction in the risk of morbidity and mortality. Macitentan administered once daily provided a significant and clinically relevant reduction in the risk of morbidity and mortality. Reuters. 10/23/12.

Actelion submits a New Drug Application to the FDA for macitentan (Opsumit™) for the treatment of patients with pulmonary arterial hypertension. Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN. Reuters. 10/22/12. (Also see What is Pulmonary Hypertension?)

Opsumit Patient Stories

(Update) Sherri M: CREST Syndrome. I have been put on Opsumit for the Pulmonary Hypertension. I have been on it for ten weeks now. I started to notice a tiny difference at around week 7; I felt just a little less short of breath… Posted 08/24/2015.

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