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Arena Pharmaceuticals (ARNA): Locaserin- Obesity Pill for FDA
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by Jordan Yerman | September 18, 2009 at 07:18 am
156 views | 4 Recommendations | 1 comment
Arena Pharmaceuticals (ARNA) has created an obesity pill called lorcaserin, which is positioned to meet with FDA approval by 2011. Arena Pharmaceuticals is calling lorcaserin a huge vicotry because of its lack of major side effects, but lorcaserin underperforms at its primary task when compared to other entries in the obesity-pill field.
Arena, Vivus Inc., based in Mountain View, California, and San Diego-based Orexigen Therapeutics Inc. are vying to bring to market new treatments targeting the 400 million adults worldwide who are obese. Even with weight loss that’s “not overly impressive,” lorcaserin is likely to be approved by 2011 and may achieve peak sales of $600 million, Jon LeCroy, an analyst at Hapoalim Securities in New York, wrote Sept. 14 in a note to investors.
It's not enough for a pill to not kill you or not turn you blue: it also has to actually do what its sellers claim it can do, according to its 4008-patient study. This is where lorcaserin seems to fall short, and its stock is actually falling today.
Under FDA guidelines for clinical trials of obesity treatments, one of two goals must be met. A trial must show that at least 35% of the drug group lost at least 5% of body weight, but that group must be approximately double the percentage of patients with similar weight loss on the placebo. Alternatively, a study can show that patients had an average weight loss that was at least five percentage points higher than the placebo group's loss.
Lorcaserin's test group only lost 3.1% more weight than the control group.
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at 10:55 on September 24th, 2009
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