Patients with FDA-defined Valvulopathy Permitted to Enroll in 2nd and 3rd
Pivotal Trials - Echocardiogram Screening Requirement Eliminated
SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the initiation of patient screening in the second and third Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients. Known as BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients. Consistent with Arena's proposal, the Food and Drug Administration, or FDA, is allowing patients with FDA-defined valvulopathy to enroll in both BLOSSOM and BLOOM-DM. This is different from the design of the initial lorcaserin pivotal study known as BLOOM, in which echocardiography was used to screen for patients with FDA-defined valvulopathy and exclude those patients from enrolling in the trial. Instead, in BLOSSOM and BLOOM-DM, there are no such echocardiographically defined exclusion criteria, although serial echocardiograms will be obtained to extend the lorcaserin safety database. BLOOM, BLOSSOM and BLOOM-DM comprise the entire planned pivotal trial program for lorcaserin.
"Eliminating the requirement of screening echoes, and receiving
permission from the FDA to expand the patient population of the lorcaserin
pivotal trial program to include patients with FDA-defined valvulopathy, is
|SOURCE Arena Pharmaceuticals, Inc.|
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