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FDA Approves New Diet Pill

Tim Boyer's picture
Belviq XR for weight loss

Here’s the latest on a one-a-day diet pill the FDA recently approved that could be on the shelves by this fall.


According to Arena Pharmaceuticals and the FDA, a new diet pill―Belviq XR (lorcaserin HCl) extended-release—is given the “Go” for manufacturing and sale in the U.S. this fall.

Belviq XR is a new extended release formulation of the parent diet drug, Belviq that works by activating serotonin receptors in the brain. Serotonin relays signals between brain cells and is known primarily for regulating mood and behavior. Belviq works by suppressing appetite and increasing feelings of satiety after eating smaller amounts of food than usual for an individual.

The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss.

"With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management," said Dr. Louis J. Aronne, M.D., principal investigator of the Belviq clinical trials. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."

Based on carefully designed research―a bioequivalence and bioavailability study comparing of once-daily BELVIQ XR 20 mg with twice-daily BELVIQ 10 mg in two Phase 1 clinical trials using healthy adult test subjects― adverse events found with the extended release formulation were similar to those seen in Phase 3 clinical trials of BELVIQ 10 mg used twice daily.

The studies show that BELVIQ XR is proven to be slowly absorbed in the body, causing it to last throughout the day and is an improvement over the older BELVIQ that was a 10 mg twice-daily formulation. The once-daily extended release formulation is determined to be effective for weight loss in conjunction with a reduced-calorie diet and increased physical activity.

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BELVIQ is recommended for those adults in need of chronic weight management help who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes.

"We're excited to offer this once-a-day option of lorcaserin," said Andrew Satlin, M.D., Executive Vice President, Neurology Business Group, Eisai Inc. "This option may provide another choice for patients who are overweight or obese and find it difficult to lose weight through diet and exercise alone. The development of this new formulation further underscores Eisai's ongoing commitment to help address the health care needs of this underserved population."

Additional Weight Loss Content

For more about more about diet pills, supplements and dieting, here is Your Weight Loss Guide for 2016.


FDA.gov―FDA Approved Drug products: BELVIQ XR

StreetInsider.com “Eisai, Arena Pharma (ARNA) Announce FDA Approval of BELVIQ XR ER; Arena to Receive $10M Milestone Payment