Vivus has received approval from the US Food and Drug Administration (FDA) for its Qsymia as an adjunct to a reduced-calorie diet.
Qsymia will be used to manage chronic weight in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity.
Vivus president Peter Tam said Qsymia is the first FDA-approved once daily combination treatment for patients struggling with obesity.
"The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia,'' Tam added.
''It is expected that Qsymia will be available in the fourth quarter of 2012."
Qsymia received approval only with a Risk Evaluation and Mitigation Strategy (REMS), which is aimed to inform prescribers and female patients of potential reproductive risks associated with the drug.
Following the approval of Qsymia, Vivus is expected to conduct post-marketing studies.
The common reactions for patients treated with Qsymia include tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.
