A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

Inclusion criteria

• Obese adults 30 - 65 years old (inclusive);
• Women of child-bearing potential must be using adequate contraception;
• BMI between 30 and 40 kg/m2 (inclusive);
• Diagnosis of OSA syndrome with Apnea/Hypopnea Index (AHI) of 15 or greater;
• Unwilling or unable to comply with CPAP treatment;

Exclusion criteria

• Known allergy or hypersensitivity to phentermine or topiramate;
• Sleep disorder other than OSA syndrome;
• Women who are pregnant, breast feeding, or intend to become pregnant during the study;
• Presence of unstable angina or heart failure corresponding to NYHA functional class III or IV;
• History of myocardial infarction or coronary revascularization within the past year; any history of stroke;
• Presence of any clinically significant abnormality on electrocardiogram;
• Use of any prescription CNS stimulants;
• History of cholecystitis or cholelithiasis unless treated by cholecystectomy;
• History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
• Weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 months;
• Previous bariatric surgery;
• Shift workers or any subjects with a circadian rhythm disorder;
• Professional drivers or commercial pilots;
• History of nephrolithiasis;
• More than one lifetime episode of major depression;
• History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder; history of any psychiatric hospitalization;
• History of a seizure disorder; concurrent use of any anticonvulsant drug (other than assigned study drug);