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Arena Pharmaceuticals Inc.

ARENA PHARMACEUTICALS INC. (San Diego CA) said that its obesity drug candidate lorcaserin succeeded in a clinical study, but the drug did not appear to be as effective as other treatments competitors have in development. Arena said lorcaserin met its goals in the study, as patients in the study who took the drug lost more weight than those who took a placebo. The company plans to file for FDA approval in December. However lorcaserin did not match the effectiveness of Orexigen Therapeutics Inc.'s (San Diego CA) drug Contrave and Vivus Inc.'s (Mountain View CA) Qnexa. Those companies reported late-stage study results earlier this year. Arena said patients who took 10 milligram tablets of lorcaserin per day lost an average of 14.3 pounds, or 6.5% of their body weight, and patients who took the drug twice a day lost an average of 17 pounds, or 7.9% of their weight. Patients who took a placebo lost 8.7 pounds, or 3.9% of their weight, on average. The company said 53.1% of the once-per-day group and 63.2% of the twice-per-day group lost at least 5% of their weight, compared with 34.9% of placebo patients. That measurement is important in gaining FDA approval.

However, in studies released earlier this year, Qnexa led to weight loss of 13% to 15%, and Contrave patients lost more than 8% of their weight. The trial was called Blossom, and involved 4,008 patients with a baseline weight of 220 pounds. Arena said a total of 7,190 patients were involved in two late-stage studies of the drug. A program of moderate diet and exercise is standard for all patients in late-stage studies of obesity drugs. According to FDA guidelines, obesity drug candidates must lead to weight loss of at least 5% for at least one-third of clinical trial patients to gain approval. At least twice as many patients on the drug must reach the 5% goal compared with patients taking a placebo.
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Title Annotation:CORPORATE
Article Type:Brief article
Date:Sep 21, 2009
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