U.S. Food and Drug Administration
Arena and Eisai Announce Completion of Study Measuring Lorcaserin Concentrations in Human Cerebrospinal Fluid and Related Analyses
Published in Medical Letter on the CDC and FDA, August 21st, 2011
2011 AUG 21 -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announcedtoday the completion of a clinical study that measured lorcaserin concentrations in human cerebrospinal fluid (CSF) and plasma and related data analyses. The study was conducted to provide additional data that may be informative for determining the human relevance of the observation of brain astrocytoma in male rats. Using the results of this study and other preclinical and clinical studies, Arena estimates that the mean exposure of the human brain to lorcaserin at the clinically tested dose (10 mg dosed twice daily (BID)) is approximately 1.7 times the exposure in the human plasma. In contrast,...
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