From Pharmacy Drug Guide
Lorcaserin hydrochloride, an Arena pharmaceuticals weight loss drug which is marketed as Belviq®, was approved by the FDA on June 27, 2012. Belviq® is approved for use with diet and exercise among adults with a body mass index (BMI) of at least 30, or 27 if the patient is suffering from weight-related illness such as Type 2 diabetes. Belviq® is the first diet drug to gain FDA approval in 13 years.
|Uses||Treatment of obesity|
|PDUFA Date||October 22, 2010|
|Disclaimer||The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.|
Lorcaserin Side Effects
The most recent Lorcaserin trial demonstrated that diabetic patients achieved a placebo-adjusted weight loss of 3%. The FDA, however, expects obesity drugs to show a minimal efficacy of 5% placebo-adjusted weight loss. Almost half of non-diabetic patients did lose 5% of their body weight on lorcaserin. The most frequently reported adverse events in this study were headaches, upper respiratory infections, back pain and nasopharyngitis.
Upon Lorcaserin's initial FDA rejection, there was concern that the drug would cause heart problems. However, the newest studies showed that such problems do not occur with the low dosages that Lorcaserin will come in. Still, there are six post-market studies slated to learn if Lorcaserin causes heart disease.
FDA Advisory Committee Testimony
Lorcaserin FDA Approval Process
- December 22, 2009: Arena Pharmaceuticals submits New Drug Application (NDA) to FDA for Lorcaserin for weight management
- February 24, 2010: Arena Pharmaceuticals Announces FDA acceptance of Lorcaserin NDA for filing
- February 26, 2010: Arena Pharmaceuticals receives Prescription Drug User Fee Act (PDUFA) date for lorcaserin NDA
- September 16, 2010: FDA Endocrinologic and Metabolic Drugs Advisory Committee found that the benefits do not outweigh the risks, and recommended that the Lorcaserin NDA be rejected.
- October 22, 2010: FDA declines to approve Lorcaserin
- November 9, 2010: Arena Pharmaceuticals releases results of Phase III study BLOOM-DM, showing what the company believes to be significant weight reduction among overweight and obese patients with type 2 diabetes.
- January 3, 2012: Arena Pharmaceutical submitted a response to the FDA which included new data and analyses not included in the original NDA.
- January 10, 2012: The FDA accepted Arena's resubmission for filing and review, and issued a new PDUFA target date of June 27, 2012.
- May 10, 2010: Expert advisers to the FDA recommended that lorcaserin be approved, stating that lorcaserin's benefits "outweigh the potential risks when used long term".
- June 27, 2012: FDA announces approval.
Lorcaserin is a selective serotonin 2C receptor agonist which acts on the area of the brain that is involved in the control of appetite and metabolism. Lorcaserin claims to promote weight loss without the heart problems that caused fen-phen (which contained the non-selective serotonin agonist fenfluramine) to be pulled from the market.
The results of a study sponsored by Arena Pharmaceuticals, and published in the July 15, 2010 issue of the New England Journal of Medicine, demonstrated that patients who took Lorcaserin for a year lost 4 kg more than those treated with a placebo.
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