Remodulin in PAH:
From the UTHR 2nd quarter PR:
>>As previously disclosed, the United States Food and Drug Administration (FDA) approved both subcutaneous and intravenous use of Remodulin on the condition that United Therapeutics complete a Phase IV post-marketing clinical study to confirm the clinical benefits of Remodulin. The FDA-approved protocol for this study permits an interim assessment of efficacy after 21 patients have completed the study and the opportunity to successfully end the study based on positive interim efficacy results.
In July 2005, 21 patients completed the study and United Therapeutics chose to perform the interim assessment. The results of the interim assessment from these 21 patients, as provided by an independent statistician, are positive (p = 0.0006). Specifically, 13 of 14 patients (93%) in the Remodulin arm were able to successfully transition from Flolan® and complete the study without the need to institute rescue therapy, compared to only 1 of 7 patients (14%) in the placebo arm.
Based on this positive outcome, United Therapeutics has submitted the interim study results to the FDA and has requested permission to end the Phase IV clinical study in satisfaction of its Phase IV commitments. By agreement with the FDA, enrollment in the Phase IV clinical study will be suspended pending FDA review and acceptance of the interim study results. United Therapeutics can give no assurances as to timing and outcomes of this FDA review.<<
Today's PR:
>>SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 19 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR - News) announced today the preliminary results of its 45-patient placebo-controlled TRUST trial are positive, (p=0.00767). Specifically, intravenous Remodulin produced an 83-meter median improvement in six-minute walk distance compared to placebo after twelve weeks in patients with NYHA Class III/IV pulmonary arterial hypertension. Supporting and secondary endpoint analyses of the study results are ongoing. "We are very pleased that this first-ever placebo controlled study of intravenous therapy in patients with pulmonary arterial hypertension overwhelmingly confirmed the efficacy of Remodulin," said Michael Wade, Ph.D., Vice President, Product Development. "We look forward to completing the confirmatory and secondary analyses and preparing the results for publication and further regulatory submissions." The TRUST trial was commenced in March 2005 to further assess the clinical benefits of Remodulin and was initially designed to enroll up to 126 patients, with interim assessments permitted after 33, 66 and 99 patients completed the study. As previously reported, enrollment of new patients was suspended in August 2005 after 45 patients had been enrolled as recommended by the trial's independent Data Safety Monitoring Board.
TRUST is an acronym for "TRUST-1: Treprostinil I.V. for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin in Patients in India with Pulmonary Arterial Hypertension (PAH)".<<
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Cheers, Tuck |
