VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication. The study announced today demonstrated statistically significant improvement in the apnea/hypopnea index ("AHI" - a measure of the severity of sleep apnea) in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients also experienced significant weight loss, improvements in blood pressure, and overnight blood oxygen levels. OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Approximately 18 million Americans have sleep apnea.
"Obstructive sleep apnea is a serious condition with recognized cardiovascular and metabolic consequences, including premature death. Current treatment approaches are limited to devices or surgery," stated Leland Wilson, chief executive officer of VIVUS. "We know that substantial weight loss can significantly improve sleep apnea. These phase 2 data suggest that Qnexa, if approved for this indication, may be a promising treatment for OSA. We have submitted the study results for presentation at a scientific meeting. We also look forward to meeting with the FDA to discuss the results of this study and to determine the regulatory path for approval."
Currently, there are no approved pharmacologic treatments for OSA.
The apnea/hypopnea index is the standard measure of OSA severity, indicating the number of apnea/hypopnea events per hour of sleep. The phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including 45 obese men and women (BMI 30 to 40 kg/m2, inclusive), 30 to 65 years of age. Patients enrolled were diagnosed with OSA based on an AHI greater than or equal to 15 (moderate to severe) at baseline. In addition to receiving active or placebo drug, all patients were provided with an intensive lifestyle modification program.
Highlights of the study include: