Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

April 11, 2016

Patients treated with Qnexa for 28 weeks had a nearly two-fold improvement in mean AHI compared with placebo Qnexa treatment reduced the number of apnea/hypopnea events from a mean of 45.5 events per hour of sleep to 14.0 - compared to placebo patients with a reduction from a mean 43.5 events per hour of sleep to 27.0 (LS Mean, ITT-LOCF>Qnexa treated patients lost 10.3% body weight, or 23.7 lbs, in 28 weeks, compared to 4.2% for placebo patients, or 10.4 lbs (LS Mean ITT-LOCF p<0.001 active vs. placebo). Systolic blood pressure was reduced by 15 mm Hg in the Qnexa group from a mean of 138 mm Hg at baseline (LS Mean ITT-LOCF>Diastolic blood pressure was reduced by 6.3 mm Hg in the Qnexa group from a mean of 87 mm Hg at baseline (LS Mean ITT-LOCF>Mean overnight oxygen saturation was significantly improved in Qnexa patients>Qnexa patients had a net reduction in the sleep arousals per hour of 19.5 versus an increase in sleep arousals of 21.2 for the placebo group.Qnexa patients also had improvement in sleep quality as measured by a reduction in the Pittsburgh Sleep Quality Index (PSQI) as compared to the placebo group>Overall study completion rate was 88.9%.Qnexa treatment was well-tolerated with no serious adverse events reported in the Qnexa arm. The most common treatment-emergent adverse events were dry mouth, altered taste, sinusitis, upper respiratory infections, nasopharyngitis, paresthesia, diarrhea and constipation. Most of these adverse events were mild or moderate in severity.

"A safe and effective treatment for obstructive sleep apnea would be valuable for the sleep physician community and for the millions of patients living with this dangerous and often undiagnosed disorder," stated Leland Wilson, chief executive officer of VIVUS. "These phase 2 data indicate that the substantial weight loss achieved with Qnexa can significantly improve sleep apnea as measured by the apnea/hypopnea index. Patients in the study had improvements in multiple secondary endpoints including improvements in their sleep quality.  We are pleased that Dr. Winslow is sharing these exciting data with the sleep community at SLEEP 2010, and we look forward to working with the FDA to determine a regulatory path forward for this indication."