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news.Encysive Pharmaceuticals has submitted a new drug application with the FDA for Thelin as a once-daily oral treatment for patients with pulmonary arterial hypertension.
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The new drug application (NDA) contains the largest database ever assembled in a regulatory filing for pulmonary arterial hypertension (PAH), with approximately 900 PAH patients receiving Thelin (sitaxsentan) in clinical evaluations.
Encysive has conducted two randomized, placebo-controlled pivotal phase III studies in support of worldwide product registrations. The second pivotal phase III trial, STRIDE-2, was conducted under a special protocol assessment (SPA) with the FDA and met its primary objective of improved six-minute walk, with a statistically significant increase of 31.4 meters over placebo.
Thelin also demonstrated a potential advantage in safety in this trial. The 100mg dose of Thelin was associated with a 3% rate of liver function abnormality in the 18-week study, compared to 6% for placebo and 11% for bosentan (Actelion’s Tracleer), the only currently approved oral therapy for PAH.