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Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management
Date:12/22/2009

s first-line therapy for weight management."

Phase 3 Program Overview

BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basis of the lorcaserin NDA submission. These double-blind, randomized, placebo-controlled trials evaluated 10 mg of lorcaserin dosed once or twice daily versus placebo for up to two years in obese patients, Body Mass Index (BMI) 30 to 45, with or without co-morbid conditions and overweight patients, BMI 27 to 29.9, with at least one co-morbid condition. Positive results from the pivotal program were presented at the 69th Scientific Sessions of the American Diabetes Association and the 27th Annual Scientific Meeting of The Obesity Society.

In addition to the pivotal program, Arena is evaluating lorcaserin in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. BLOOM-DM is planned as a supplement to the NDA.

About Lorcaserin

Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic
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SOURCE Arena Pharmaceuticals, Inc.
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