Qnexa

Qnexa is a new drug targeted at diabetes from VIVUS, currently undergoing clinical trials.

Basically Qnexa is combination of phentermine and an epilepsy drug Topamax (also used for migraines) .

From the VIVUS site:

“Qnexa is a proprietary therapeutic formulation and dosing regime that incorporates the active ingredients from two previously approved products with demonstrated weight loss properties. By combining the activity of each of these compounds, Qnexa simultaneously addresses appetite and satiety, the two main mechanisms that impact eating behavior. ”

July 1, VIVUS announced positive results from their Phase II Clinical Trials with Qnexa. “A subset analysis of subjects with higher cardiovascular risk factors at baseline had significantly greater improvements on Qnexa as compared to placebo.” Source: Medical News Today.

August 4, 2008 Vivus released their 2Q Earnings, and VIVUS President and CEO, Leland Wilson said regarding the results of the Phase II Clinical Trial or the OB-202 study, “The primary endpoint of this trial was a reduction in hemoglobin A1c. Subjects on Qnexa achieved a reduction in A1c of 1.2%. Importantly, Qnexa patients also achieved an average weight loss of 8%, an improvement in their cardiovascular risk factors, namely blood pressure, triglycerides, and weight circumference.

We believe Qnexa is the first oral diabetic medication to significantly lower blood sugar, weight and cardiovascular risk.”

More on the Qnexa trial: The Qnexa trial involved 200 subjects, 159 women and 41 men with an average age of 40 and a mean body mass index (BMI) of 38. Each subject in the study received daily doses, consisting of Qnexa, placebo, or each one of the active ingredients separately. Subjects were asked to reduce caloric intake by 500 calories per day. The most common adverse effects reported were nausea, paresthesias, constipation, dry mouth and dizziness.

What’s next for Qnexa?

Phase II Clinical Trials.

VIVUS will meet with the FDA later this year to discuss the details of a Phase III development program for diabetes.

All Qnexa Phase III Clinical Trials are fully enrolled and are progressing. Data from the OB-301 study is expected to be available by the end of 2008, and data from the OB-302 and 303, the one year studies are expected to be available by mid-2009.