The incidence of targeted medical events for sleep disorders, depression, anxiety, cardiac disorders and cognitive disorders in SEQUEL was lower than observed during the one-year CONQUER study.
Similar to previously presented data, effects of QNEXA in SEQUEL on heart rate were small and seen in conjunction with improvements in blood pressure from baseline. There were no clinically relevant decreases of serum bicarbonate in QNEXA-treated patients compared to placebo in year two of SEQUEL.
Across the entire QNEXA development program (4,323 patients), including the two-year data in SEQUEL, serious cardiovascular and neurovascular adverse event rates in patients taking QNEXA were similar to placebo with a relative risk of 0.59 (95% CI: 0.33-1.06). No teratogenic effects were observed across the entire development program in patients taking QNEXA.
"These two-year data provide further reassurance that QNEXA may fill a significant medical need for this at-risk, co-morbid population struggling to lose weight and keep it off," said Leland Wilson, chief executive officer of VIVUS. "We look forward to presenting and publishing additional data from SEQUEL, including secondary efficacy endpoints for decreasing co-morbidity risks, in the future."
About QNEXA Controlled Release CapsulesQNEXA [kyoo-nek-suh] is an investigational drug being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which together decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and imp
|SOURCE VIVUS, Inc.|
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