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Pivotal Data Demonstrating Efficacy of Plenadren® (Hydrocortisone, Modified Release Tablet) in Adrenal Insufficiency Published in the Journal of Clinical Endocrinology and Metabolism
Date:2/16/2012

EXTON, Pa., Feb. 16, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced that data from the pivotal study for their orphan drug Plenadren® (hydrocortisone, modified release tablet) were published in the Journal of Clinical Endocrinology and Metabolism (JCEM), a leading scientific journal for endocrinology. Plenadren was recently granted European Marketing Authorization for treatment of adrenal insufficiency in adults.

The authors described results showing that the once daily dual-release tablet provided a more circadian-based serum cortisol profile, and that reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during once daily treatment, compared to treatment with immediate release hydrocortisone three times per day.  In particular, the authors noted glucose metabolism improved in patients with concomitant diabetes mellitus. In addition, the preference of once daily versus three times per day treatment was assessed to be large or very large by 85 percent of patients at 12 weeks.

Professor Gudmundur Johannsson of the Department of Endocrinology, Sahlgrenska University Hospital, Gothenburg, Sweden, and primary author of the publication, commented, "These data indicate that patients with Addison's Disease now have an important therapeutic option with once daily Plenadren.  The time-exposure of Plenadren may be important in improving the outcome of patients suffering with adrenal insufficiency." 

Replacement therapy for the treatment of the rare disease adrenal insufficiency has been available for more than 50 years. Oral hydrocortisone is the most widely used replacement therapy for treatment, but no formal studies of its efficacy and safety have been performed in patients suffering from adrenal insufficiency. The JCEM publication entitled, 'Improved Cortisol Exposur
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SOURCE ViroPharma Incorporated
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