You are here

Extended-Release Lorcaserin (Belviq XR) Wins FDA Nod

Product offers once-daily dosing option

The FDA has approved the new drug application for Belviq XR (lorcaserin, Eisai Inc./Arena Pharmaceuticals) CIV extended-release 20-mg tablets. The new formulation is designed to offer patients a once-a-day dosing option.

Both the original 10-mg twice-daily formulation of Belviq and the newly approved 20-mg once-daily extended-release formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese) or a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as hypertension, hypercholesterolemia, or type-2 diabetes.

It is not known whether Belviq or Belviq XR, when taken with other prescription, over-the-counter, or herbal weight-loss products, is safe and effective. It is not known whether Belviq or Belviq XR changes a patient’s risk of heart problems, stroke, or death due to heart problems or stroke.

The bioequivalence and bioavailability of once-daily Belviq XR 20 mg compared with twice-daily Belviq 10 mg were based on two phase 1 registrational clinical trials in healthy adult subjects. The most common treatment-emergent adverse events were similar to those seen in phase 3 trials of Belviq 10 mg twice-daily.

Both Belviq and Belviq XR are federally controlled substances (CIV) because they may be abused or lead to drug dependence.

Source: Eisai; July 19, 2016.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs