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Data From QNEXA Sequel Study Featured at the 47th EASD Annual Meeting
Date:9/16/2011

r showing long-term QNEXA data on glycemic effects in type 2 diabetic patients (N=145) from the two-year SEQUEL study. In the SEQUEL diabetic sub-group, greater percent weight loss was achieved with QNEXA when compared to placebo at week 108 (9.0% in the mid- and top-dose QNEXA and 2.0% placebo within the diabetic sub-group 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 (P=0.0130).  

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=0.0031), 27.6% top-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 (P= 0.0050).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.

About QNEXA Controlled Release CapsulesQNEXA [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA
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SOURCE VIVUS, Inc.
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