Arena Pharmaceuticals says its prescription weight loss drug Belviq will be available to U.S. patients beginning next week, nearly a year after the drug was officially approved by federal regulators.
The FDA approved Belviq last June for adults who are obese or who are overweight and have at least one serious medical condition, such as diabetes or high cholesterol.
Belviq's launch was delayed for months by logistical hurdles, including classification by the DEA. According to the drug's label, Belviq will be classified as a Schedule IV controlled substance, which means it has a low potential for abuse. A small segment of patients in company studies reported experiencing euphoria and hallucinations.
Arena Pharmaceuticals and partner Eisai Co. said the drug will be available beginning Tuesday, June 11. Under an agreement between the companies, Arena will manufacture and supply the drug from its facility in Switzerland and Eisai will market the drug in the U.S.
Arena's studies showed that patients taking Belviq, known generically as lorcaserin, lost just 3% to 3.7% of their weight over a year. About 47% of patients without diabetes lost at least 5% of their weight or more, which was enough to meet FDA standards for effectiveness.
The FDA said patients should stop taking Belviq after three months if they fail to lose 5% of their body weight. Patients are unlikely to see any significant weight loss by staying on the drug, the agency said.
Side effects with the drug include depression, migraine and memory lapses.
Contrary to the usual stock analyst forecasts of a "billion dollar diet drug", Piper Jaffray stated that it forecasts U.S. Belviq sales of $68 million in 2013, although Esai management predicted sales of $150 million during the first nine months of launch through march 2014. We'll see.