Once-Daily Formulation of Belviq Under FDA Review

The FDA has accepted Eisai Co Ltd's new drug application for a once-daily formulation of its anti-obesity treatment lorcaserin hydrochloride.

The FDA has accepted Eisai Co Ltd’s new drug application for a once-daily formulation of its anti-obesity treatment lorcaserin hydrochloride (Belviq).

Belviq has been available in the United States as a twice-daily formulation since 2013.

The serotonin 2C receptor agonist was approved by the FDA in 2012 as an adjunct to a reduced-calorie diet and increased physical activity for overweight patients.

Adverse effects associated with Belviq include headache, dizziness, fatigue, nausea, and dry mouth.

The medication is also currently being investigated in a cardiovascular outcomes trial, which is looking at Belviq's potential to cause major adverse cardiovascular events. Results from this study will become available in 2018.

A phase 2 clinical trial demonstrated that Belviq could be an effective smoking cessation aid.

Around 170 million people in the United States are obese or overweight.