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S Stage II trial of droxidopa in fibromyalgia.

The objective of this planned DMC meeting was to review the efficacy of each dose group and determine if the efficacy data backed dropping underperforming arms in order to increase the power in those arms most likely to show a clinically relevant therapeutic benefit. Following their assessment of each of the 12 hands using the study's principal endpoint, a reduction in pain as measured by the Short Form McGill Discomfort Questionnaire, the DMC recommended that 7 of the 12 hands of the trial be continued to completion. This recommendation was based solely on the efficacy analysis, as there have been no observed safety issues associated with any arm of the analysis. As a total result of this recommendation, the study will now focus primarily on multiple dosages of droxidopa in conjunction with 50mg carbidopa.Arena fourth quarter net loss decreases to $28.2 million Arena Pharmaceuticals, Inc. today reported economic results for the 4th quarter and full 12 months ended December 31, 2010, and reviewed recent advancements. ‘Our focus is dealing with Eisai to acquire FDA authorization of lorcaserin, preparing to submit an application for European authorization of lorcaserin, and advancing select earlier-stage development and research programs on our very own or in collaboration,’ said Jack Lief, Arena’s President and CEO.