The FDA initially rejected Vivus‘ drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
The agency also said patients with recent or unstable heart disease or stroke aren’t good candidates for the drug because its effect on heart rates in those patients is not known. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout.
The pill will launch with a relatively small sales force of 150 representatives. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
“We’re going to have to grow our sales organization in order to support the primary care market,” Vivus President Peter Tam said in an interview with the Associated Press.
Rival Arena Pharmaceuticals Inc. of San Diego plans to start selling Belviq early next year. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.