Once-Daily Lorcaserin Extended-Release Gets US OK for Obesity

July 19, 2016

The US Food and Drug Administration (FDA) has approved an extended-release 20-mg, once-daily dosing option of lorcaserin, to be known as Belviq XR, for the treatment of obesity.

Belviq XR is slowly absorbed and lasts throughout the day, and is expected to be available in the fall of 2016, say Eisai and Arena Pharmaceuticals, who developed the product.

Lorcaserin is already approved as a 10-mg twice-daily formulation (Belviq, Eisai/Arena Pharmaceuticals).

Both Belviq and the new Belviq XR formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related medical condition, such as hypertension, hypercholesterolemia, or type 2 diabetes.

"With approximately two-thirds of the US population living with extra weight or obesity, there is a significant and growing need to address chronic weight management," notes Louis J Aronne, MD, director of the comprehensive weight control center at Weill Cornell Medicine, and principal investigator of the Belviq clinical trials, in a press release issued by the companies.

"Having a once-daily treatment may offer an option for patients to stay on track to meet their weight-loss goals," he added.

The bioequivalence and bioavailability of once-daily Belviq XR 20 mg compared with twice-daily Belviq 10 mg was based on two phase 1 registration clinical trials in healthy adults. The most common treatment-emergent adverse events were similar to those seen in phase 3 clinical trials of Belviq 10 mg twice-daily, say the companies.

Belviq XR Will Join Other Once-Daily Formulations for Obesity

A once-daily oral formulation of lorcaserin may be able to compete on a more even footing with some of the newer obesity medications on the US market that only need to be taken once daily, including phentermine/topiramate (Qsymia, Vivus) and the subcutaneously injected glucagonlike peptide-1 (GLP-1) agonist liraglutide (approved for use in obesity as Saxenda, Novo Nordisk).

Another agent, naltrexone/bupropion (Contrave, Orexigen) is indicated initially as a once-daily oral tablet but titrated to a maximum of two tablets, twice a day. Another oral medication, orlistat (available as Xenical on prescription, Genentech, or Alli over the counter, GlaxoSmithKline) needs to be taken every 8 hours.

Doctors seem reluctant to prescribe obesity drugs; however, a recent Medscape survey indicated some of this is because of historical concerns regarding adverse effects of previous obesity medications, some is physicians not being convinced of the efficacy of these agents, and some is due to lack of insurance coverage of the newer agents, meaning patients have to pay out of pocket for them.

The most commonly prescribed weight-loss drugs in the survey were in fact generic phentermine and generic bupropion.

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