New weight-loss pill gets health approval
A new weight loss pill developed in 2009 and awaiting Food and Drug Administration (FDA) approvals in the United States has generated considerable interest amongst the medical community because of the stated absence of serious side-effects.
The pill called Lorcaserin was developed last year by Arena Pharmaceuticals and submitted for a new drug application or NDA with the FDA. Trial data published in the New England Journal of Medicine this week suggests that the pill does help reduce without any side-effects on obese people.
Lorcaserin also contains improved biomarkers that may predict future cardiovascular events, including lipid levels, insulin resistance, levels of inflammatory markers and blood pressure.
"There is significant and growing needs for effective treatment options that can help patients reduce their weight in a well-tolerated and safe manner," says Steven R. Smith, M.D., Scientific Director of the Florida Hospital Translational Research Institute for Metabolism and Diabetes, in the article.
A two-year study using Lorcaserin titled `Behavioural modification and Lorcaserin for Overweight and Obesity Management’ (BLOOM) was conducted by Arena Pharmaceuticals, Inc. and Eisai Inc. Patients who took the weight loss pill for one year of the BLOOM trial lost an average 8.2 percent of their baseline weight besides improving their cardiovascular risk factors, he says.
BLOOM trials involved 3,182 patients in 98 sites across the United States. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients. At the end of the first year, the proportion of patients achieving at least five per cent weight loss in the lorcaserin group (47.5%) was twice more than what the placebo group achieved (20.3%).
Nearly three times as many patients achieved at least 10 percent weight loss in the lorcaserin group (22.6%) in comparison with the placebo group (7.7%).
In the first year, lorcaserin caused significant decreases in waist size, BMI, glycemic parameters, high-sensitivity C-reactive protein and fibrinogen levels. The weight-loss drug is known to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism.