Multiple abstracts on QNEXA presented at 47th EASD

VIVUS, Inc.Sep 17 2011

VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts were presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal.  The presentations highlighted the long-term beneficial effects of QNEXA treatment in metabolically-impaired patients with prediabetes, diabetes, and metabolic syndrome.

The QNEXA presentations included:  

• Decreased Progression to Diabetes in Subjects With Prediabetes After 2 Years of Treatment With Controlled-Release Phentermine/Topiramate, authored by W. Timothy Garvey, MD, et al.
• Long-Term Weight Loss With Controlled-Release Phentermine/Topiramate Reverses Metabolic Syndrome and Improves Associated Traits, authored by Hermann Toplak, MD, et al.
• Long-Term Glycaemic Effects of Weight Loss With Low-Dose, Controlled-Release Phentermine/Topiramate in Overweight/Obese Subjects with Diabetes, authored by Luc F. Van Gaal, MD, et al.

Highlights from the EASD presentations are as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported that patients treated over two years with QNEXA had significant reductions in the progression to type 2 diabetes and improvement in glycemic status. Of the 675 patients in the two-year SEQUEL study, 316 were determined to have prediabetes at baseline. In the prediabetic sub-group treated with QNEXA, all glycemic parameters were significantly improved at week 108 (ITT-LOCF; P<0.05 vs. placebo). Progression to diabetes was reduced in the prediabetic sub-group with top-dose QNEXA vs. placebo.

Luc Van Gaal, MD from the University of Antwerp in Belgium and Lawrence Cheskin, MD from Johns Hopkins University Weight Management Center authored a poster showing long-term QNEXA data on glycemic effects in type 2 diabetic patients>P≤0.0003). Within the diabetic sub-group, improvements were seen in fasting glucose, fasting insulin and hemoglobin A1c in the QNEXA-treated groups. The QNEXA-treated patients also had reduced utilization of concomitant antidiabetic medications as compared to placebo.

A poster presentation by Dr. Hermann Toplak from the Medical University of Graz, Austria focused on long-term QNEXA treatment, sustained weight loss, reversal of metabolic syndrome and improvements in associated traits. Of the 675 patients enrolled in SEQUEL, 451 (66.8%) met the criteria for metabolic syndrome. Average percent weight loss at week 108 within the metabolic syndrome sub-group was 11.1% mid-dose QNEXA, 12.2% top-dose QNEXA and 2.8% placebo (P<0.0001 vs. placebo). The percentage of patients demonstrating resolution of metabolic syndrome was significantly higher within the QNEXA treatment arms at week 108 [22.4% mid-dose>P<0.0001)] vs. 9.2% with placebo. Conversely, the percentage of patients without metabolic syndrome at baseline, who progressed to metabolic syndrome at week 108, were higher in the placebo group at 60% vs. 23% with top-dose QNEXA.

In all three analyses, the safety profile was consistent across subpopulations and the most common adverse events seen were upper respiratory infection, constipation, tingling, runny nose and dry mouth.