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Arena's Obesity Drug Lorcaserin Passes Safety Review

Armen Hareyan's picture

A new diet and obesity drug called Lorcaserin hydrochloride for the treatment of obesity from Arena Pharmaceuticals has passed a major safety board review and shows that this obesity pill doesn't damage heart valves as some other weight loss treatment drugs in the past.

Arena in it's news release about the Lorcaserin obesity treatment drug writes that the EDSMB's review of unblinded echocardiographic data performed after patients completed 12 months of dosing in the trial confirmed that differences, if any, in the rates of Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet the EDSMB's predetermined stopping criteria. Based on the EDSMB's review of the rate of FDA-defined valvulopathy, Arena has been able to confirm that the statistical power calculations used in the design of the Phase 3 trial program to monitor patients for increased risk of developing valvulopathy are justified. The findings from the month-12 review build on the EDSMB's September 2007 review that evaluated echocardiograms after 6 months of dosing.

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"This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin's cardiovascular safety profile. We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present. BLOOM's primary echo endpoint is based on the month-12 data," said Jack Lief, Arena's President and Chief Executive Officer. "We are committed to continued efforts to develop a robust database for submission to the FDA in our efforts to provide patients a novel, safe and effective obesity treatment."

Bloomberg notes that "Lorcaserin still needs to pass more heart scans, or echocardiograms, after patients in the study have been followed for 18 and 24 months, Behan said. The main goal of the trial, called Bloom, is to show that patients can lose 5 percent of their body weight if they take lorcaserin for a year.

"An earlier clinical trial found that patients who took the same 10-milligram, twice-daily dose of lorcaserin being studied in the Bloom trial lost an average of 7.9 pounds over 12 weeks, compared with 0.7 pounds for those who took a placebo, Arena has said. The earlier study, which enrolled 469 patients, found no effect on heart valves. "