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Arena and Eisai Announce Completion of Study Measuring Lorcaserin Concentrations in Human Cerebrospinal Fluid and Related Analyses
Date:8/2/2011

a concentrations in humans at the clinically tested dose of lorcaserin and in rats at the dose of lorcaserin at which no brain astrocytoma was observed; the human plasma exposure to lorcaserin 10 mg BID is approximately five times lower than the male rat plasma exposure to lorcaserin 10 mg/kg/day.

Because lorcaserin might enter the brain differently in rats and humans, relative brain exposure may more accurately estimate the safety margin than relative plasma exposure. The apparent consistent relationship of the lorcaserin brain to CSF exposure ratios in three animal species (mice, rats and monkeys) measured in five preclinical studies conducted by Arena provides a method to estimate human brain exposure by using CSF measurements from humans and assuming a similar brain to CSF ratio found in animals.

In this clinical study, lorcaserin CSF and plasma concentrations were measured in nine healthy obese volunteers after oral administration of lorcaserin 10 mg BID for seven days. On Day 7, lumbar CSF and plasma were serially collected simultaneously over a 12-hour period. Arena calculated the estimated ratio of lorcaserin exposure in the brain relative to plasma in humans using the mean brain to CSF exposure ratio from the preclinical studies of 101, with a range of 75-117, and the measured human CSF and plasma exposures (mean AUCss (standard deviation)) of 9.3 (+/-3.9) hr-ng/mL and 540 (+/-157) hr-ng/mL, respectively, from this study.

It is important to note that Arena's estimates are based on certain assumptions and extrapolations. The FDA may accept Arena's assumptions and extrapolations or may use different ones in analyzing the data, which could lead the FDA to estimate a different exposure margin. The FDA also may or may not view the estimates as reliable or predictive of the safety margin. 

About LorcaserinLorcaserin is an investigational drug candidate intended for weight management, including weight
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SOURCE Arena Pharmaceuticals, Inc.
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