NEW YORK (AP) – Arena Pharmaceuticals Inc. said that its obesity drug candidate lorcaserin succeeded in a clinical study, but the drug did not appear to be as effective as other treatments competitors have in development.
Arena said lorcaserin met its goals in the study, as patients in the study who took the drug lost more weight than those who took a placebo. The company plans to file for FDA approval in December.
However lorcaserin did not match the effectiveness of Orexigen Therapeutics Inc.’s drug Contrave and Vivus Inc.’s Qnexa. Those companies reported late-stage study results earlier this year. Arena shares dropped 25 cents, or 5.1 percent, to $4.66 in heavy morning trading.
Arena said patients who took 10 milligram tablets of lorcaserin per day lost an average of 14.3 pounds, or 6.5 percent of their body weight, and patients who took the drug twice a day lost an average of 17 pounds, or 7.9 percent of their weight. Patients who took a placebo lost 8.7 pounds, or 3.9 percent of their weight, on average.
The San Diego-based company said 53.1 percent of the once-per-day group and 63.2 percent of the twice-per-day group lost at least 5 percent of their weight, compared with 34.9 percent of placebo patients. That measurement is important in gaining FDA approval.
However, in studies released earlier this year, Qnexa led to weight loss of 13 percent to 15 percent, and Contrave patients lost more than 8 percent of their weight.
The trial was called Blossom, and involved 4,008 patients with a baseline weight of 220 pounds. Arena said a total of 7,190 patients were involved in two late-stage studies of the drug.
A program of moderate diet and exercise is standard for all patients in late-stage studies of obesity drugs.
According to FDA guidelines, obesity drug candidates must lead to weight loss of at least five percent for at least one-third of clinical trial patients to gain approval. At least twice as many patients on the drug must reach the five percent goal compared with patients taking a placebo.
In a note to clients, Lazard Capital Markets analyst Terence Flynn said the results “appear to be on border of the criteria recommended by the FDA.” The difference between weight loss for patients on lorcaserin and patients taking the placebo was smaller than what was seen in the Qnexa and Contrave trials, he said.
Flynn kept a “Hold” rating on the stock.
The most common side effects in the trial were upper respiratory infections, colds and headaches, the company said. It said depression, anxiety and suicidal thoughts were rare and occurred at similar rates in the placebo group and the lorcaserin group.
The company said the trial ruled out the risk of heart valve damage.
Arena said said 35.1 percent of patients in the twice-a-day lorcaserin group lost at least 10 percent of their weight, compared with 26.3 percent for patients who took the drug once per day, and 16.1 percent for placebo patients. improved blood pressure and fat levels, the company said.
Arena plans to report data from the most-recent study, called Blossom, and a previous study called Bloom at the 27th annual scientific meeting of The Obesity Society, scheduled for Oct. 24-28 in Washington, D.C.
Date: September 18, 2009
Source: Associated Press
Filed Under: Drug Discovery