FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Nutrition and Weight Loss
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Arena Pharmaceuticals
Approval Status: Approved June 2012
Treatment Area: weight loss management
Belviq (lorcaserin hydrochloride) is a serotonin 2C receptor agonist. It has been shown to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.
Belviq is specifically indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in clinically obese adults (BMI of 30 kg/m2 or greater) and overweight adults (BMI of 27 kg/m2 or greater) with at least one weight-related comorbid condition.
Belviq is supplied as a tablet designed for oral administration. The recommended dose is one 10mg tablet twice daily. Use of Belviq should be discontinued if 5% weight loss is not achieved by week 12 of treatment.
FDA ApprovalThe FDA approval of Belviq was based on the results of three randomized, double-blind, placebo-controlled trials with
durations ranging from 52 to 104 weeks. Study 1 and Study 2 were conducted in adults (n=3182, n=4008; respectively) without type II diabetes, and Study 3 was conducted in adults (n=604) with type II diabetes. All subjects were administered Belviq 10mg twice daily. The primary endpoint for each study was weight loss at one year as assessed by percent of subjects achieving greater than or equal to 5% weight loss, percent of subjects achieving greater than or equal to 10% weight loss, and mean weight change. Belviq was administered in conjuction with one-on-one instruction for reduced-calorie diet and exercise counseling at the first dose and at every four weeks during the trials. Study 1 was a two-year trial, and Study 2 and Study 3 were one-year trials. Statistical significance was achieved in each group of Belviq-treated subjects compared to placebo upon evaluation of 5% weight loss or greater.
Adverse reactions associated with the non-diabetic use of Belviq may include, but are not limited to, the following:
Adverse reactions associated with the diabetic use of Belviq may include, but are not limited to, the following:
Belviq (lorcaserin hydrochloride) is a serotonin 2C receptor agonist. While the complete mechanism of action is not entirely understood, it is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus.
Fidler MC, Sanchez M, Raether B, Weissman NJ, Smith SR, Shanahan WR, Anderson CM; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011 Oct;96(10):3067-77
Smith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, Bays H, Shanahan WR; Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010 Jul 15;363(3):245-56
O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized Placebo-Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: The BLOOM-DM Study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66
For additional information regarding Belviq or weight management, please visit the Arena Pharmaceuticals web page.