Vivus says obesity drug Qnexa meets goals in trial

Vivus says obesity drug Qnexa meets goals in trial
December 11, 2008
Boston.com

MOUNTAIN VIEW, Calif.—Drug developer Vivus Inc. said Thursday its obesity drug candidate Qnexa met its goals in a late stage clinical trial, as patients treated with the drug lost more weight than those who received a placebo.

Vivus said patients who took 15 milligrams of Qnexa lost an average of 19.8 pounds over the 28 weeks of the trial, and patients taking a 7.5-mg daily dose lost 18.2 pounds.

Patients who took the placebo lost an average of 3.3 pounds. The primary goal of the trial was to compare the weight loss achieved with Qnexa to weight loss in the placebo group.

The full-dose patients lost 9.2 percent of their body weight, compared with 8.5 percent for the half-dose patients and 1.7 percent on average in the placebo group. A total of 756 patients were enrolled in the EQUATE study, one of three late stage trials of Qnexa. Vivus expects to report results from two larger trials, EQUIP and CONQUER, in mid 2009.

Average starting weight in the trial was 223 pounds. For patients who took a full dose of Qnexa, or phentermine, 66 percent lost at least 5 percent of their total body weight and 41 percent lost 10 percent or more. In patients who took the smaller dose, 62 percent lost 5 percent of their weight and 39 percent lost at least 10 percent.

Among the placebo patients, 15 percent posted weight loss of 5 percent or more, and 7 percent lost 10 percent of their initial weight.

Patients in both groups were asked to reduce their diet by 500 calories per day and to use a "simple lifestyle modification program."

The drug was well-tolerated, and the most common side effects were a "pins and needles" sensation, or paresthesia, dry mouth, altered taste and constipation.

In premarket trading, Vivus shares rose 86 cents, or 13 percent, to $7.49. The stock has ranged between $4.28 and $9.27 over the last 12 months.

© 2008 NY Times Co.