Intended for weight management, including weight loss and maintenance of weight loss, lorcaserin is poised to become the next weight loss drug. Lorcaserin is aimed at clinically obese patients, or patients with a Body Mass Index, or BMI, >30, or patients who are overweight (BMI >27) and have at least one weight related co-morbid condition. Arena Pharmaceuticals, Inc. and Eisai Inc. submitted a New Drug Application (NDA) for lorcaserin on January 10th, 2012, and the FDA has accepted this resubmission. Previously submitted to the FDA in October of 2010, lorcaserin was not approved. The concern was data reported which indicated mammary tumors in female rats. As the cancer promoting properties could not be ruled out, and due to marginal weight loss results reported, a federal advisory committee voted against the approval of lorcaserin at that time.
As a selective 5-HT2C receptor agonist, lorcaserin is believed to target this receptor in the brain and hypothalamus, which are areas thought to be involved in the control of appetite and metabolism. This activation of the 5-HT2C receptors in the hypothalamus are believed to activate proopiomelanocortin (POMC) production, thus promoting weight loss through satiety. While the particulars and the exact mechanism of appetite regulation is not completely understood, lorcaserin has shown 100:1 affinity for 5-HT2C receptors versus other receptors.
Phase 2 clinical trials from Arena have demonstrated that patients who received lorcaserin experienced a significantly greater weight loss than patients who received a placebo. Another earlier trial, deemed BLOSSOM, was reported on September 18, 2009. These positive findings showed that 47. 2% of lorcaserin patients lost at least 5% of their body weight, compared to 25. 0% of patients on the placebo. Taking 10 milligrams of lorcaserin either once or twice daily, patients also experienced an average weight loss of 5. 9%, or 12. 7 pounds. This was compared to 2. 8%, or 6. 3 pounds, for patients on the placebo.
Adverse side effects reported during trials of lorcaserin included headache, dizziness, and nausea. The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012 for lorcaserin. LGM Pharma is a provider of Lorcaserin CAS# 846589-98-8 for research and development purposes. Lorcaserin has an expected trade name of Lorqess.
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