for four weeks and then switched to four weeks of the same dose of LODOTRA ® in the evening prior to sleep. After a two week screening period, patients were treated with immediate release prednisone at 8 a.m. The MONA (modified release prednisone for the treatment of nocturnal asthma) study is a two-stage, open-label, pilot trial assessing LODOTRA ®’s treatment effect in patients with severe nocturnal asthma who require treatment with oral prednisone in addition to standard asthma therapy. Food and Drug Administration later this year.” “These results underscore the versatility of the potential antiinflammatory properties of LODOTRA ®, as it has also been shown in clinical studies to significantly improve the signs and symptoms of rheumatoid arthritis in patients, an indication for which we anticipate submitting a New Drug Application to the U.S. Walbert, chairman, president and chief executive officer, Horizon Pharma. “Often, patients with severe nocturnal asthma have trouble controlling symptoms with their standard asthma therapy, and these pilot data suggest LODOTRA ® may improve patients’ quality of life and the number of times they are awakened by asthma symptoms during the night,” said Timothy P. The data were presented today during a poster session at the American Thoracic Society (ATS) 2010 International Conference in New Orleans, LA. – – Horizon Pharma, Inc., a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and chronic inflammation, today announced interim results from a pilot clinical study showing that LODOTRA ® (modified release prednisone tablet) chronotherapy may improve asthma control and asthma-related quality of life when added to standard asthma therapy in patients with severe nocturnal asthma. Presents Interim Results from a Pilot Clinical Study Evaluating LODOTRA® in the Treatment of Severe Nocturnal Asthma NORTHBROOK, Ill. Presents Interim Results from a Pilot Clinical Study Evaluating LODOTRA® in the Treatment of Severe Nocturnal Asthma 26.6 KB
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