Vivus says larger clinical trials of Qnexa expected to produce positive results

By Jennifer Lanning Drey

Eugene, Ore., Aug. 16 - Vivus, Inc.'s principal investigator for its phase 2 clinical trial of Qnexa said he is certain that larger trials for Qnexa will product results similar to those found in the phase 2 study.

Highlights from the company's phase 2 clinical trials of Qnexa include data demonstrating that more than 50% of patients experienced 10% or more total body weight loss in 24 weeks.

"My sense is with a difference as large as this, and with this kind of treatment effect, I'm very confident it's going to be replicated in larger samples and for longer duration. I have no doubts about it at all," Gadde said.

Qnexa is a proprietary pharmaceutical treatment for weight loss containing low doses of the active ingredients phentermine and topiramate.

The phase 2 clinical trial was a 24-week double-blind, placebo-controlled clinical trial comparing Qnexa, placebo, a phentermine and topiramate. Its primary endpoint was change in body weight.

Secondary endpoints were changes in blood pressure, waist circumference and lipids.

Vivus enrolled 200 patients in the phase 2 clinical trial and divided them into four treatment groups. Patients received Qnexa, phentermine, topiramate or a placebo.

In addition to demonstrating weight loss during the 24-week period, the phase 2 clinical trial also demonstrated that the weight loss had not hit a plateau at the end of the trials, according to the company.

Gadde also said Wednesday that 92% of patients completed the phase 2 clinical trial, and there were no severe or serious adverse events among patients taking Qnexa.

However, he cautioned that because of the size of the study it could not detect certain rare side effects.

"That's the kind of information that we could never get from a study like this because we had 50 people in each group. Those kinds of things will be better assessed in phase 3 studies," he said.

The company has said previously it expects those trials to begin by mid-2007.

Vivus is a Mountain View, Calif., pharmaceutical company developing therapeutic products addressing obesity and sexual health.

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