Arena Pharmaceuticals is touting the results of a major Phase III study of its weight loss drug lorcaserin. In a year-long 4,000 person study, subjects who took the drug twice a day lost 5.9 percent of their body weight compared to just 2.1 percent for those taking placebo. And there's more good news. Sixty-three percent of lorcaserin patients who completed the trial lost at least 5 percent of their weight, while the top quartile of the group lost an average of 16 percent of their weight--or about 35 pounds.
Lorcaserin works by blocking selected appetite signals in the brain. Safety data indicates that the drug doesn't carry a risk of heart valve damage--an issue that sunk the obesity drug fenfluramine in 1997. Side effects are similar to placebo and include upper respiratory infection and headache. The drug was not linked to any psychiatric side effects.
"History has taught us that the marriage of efficacy and safety is of critical importance in treating patients. Neither is sufficient without the other. With its excellent safety and tolerability profile, we expect lorcaserin to change the way primary care doctors treat the broad cross-section of overweight and obese patients with pharmacotherapy," said Jack Lief, Arena's President and Chief Executive Officer.
Arena's shares took a dive earlier this year when data from a Phase III trial of the drug didn't satisfy the FDA, which wanted to see a 5 percent weight loss difference between the lorcaserin group and placebo group. The company subsequently cut 130 workers. This time around the company met the FDA's alternate goal for a weight loss drug--47.2 percent of subjects on the drug lost 5 percent or more of their weight. Arena plans to submit an NDA for the drug in December.
- check out Arena's release on the data.
- here's the Reuters write-up