Escalating dosing regimen for effecting weight loss and treating obesity
AssigneeVivus, Inc.
InventorsThomas Najarian, Peter Y. Tam, Leland F. Wilson
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Abstract
The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Claims33
A method for effecting weight loss in a patient having a body mass index of at least 25 kg/m2, comprising administering an escalating unit dosage form comprising,
- (a) a first dosage form, comprising,
- 23 mg of topiramate, formulated for controlled release, and
- 3.75 mg of phentermine, formulated for immediate release,
- wherein the first dosage form is administered to the subject daily for at least 2 weeks;
- and
- (b) a second dosage form, comprising,
- 46 mg of topiramate, formulated for controlled release, and
- 7.5 mg of phentermine, formulated for immediate release,
- wherein the topiramate formulated for controlled release reaches maximum plasma concentration (Cmax) at about 6 to about 10 hours (Tmax) after administration and exhibits a lower Cmax, than non-controlled release topiramate, without decreasing total drug exposure defined by the area under the concentration-time curve (AUC), and
- wherein the second dosage form is administered to the subject daily for at least 2 years, thereby effecting weight loss.
A method for effecting weight loss in a patient having a body mass index of at least 25 kg/m2, comprising administering an escalating unit dosage form comprising,
- (a) a first dosage form, comprising,
- 23 mg of topiramate, formulated for controlled release, and
- 3.75 mg of phentermine, formulated for immediate release,
- wherein the first dosage form is administered to the subject daily for at least 2 weeks;
- and
- (b) a second dosage form, comprising,
- 92 mg of topiramate, formulated for controlled release, and
- 15 mg of phentermine, formulated for immediate release,
- wherein the topiramate formulated for controlled release reaches maximum plasma concentration (Cmax) at about 6 to about 10 hours (Tmax) after administration and exhibits a lower Cmax, than non-controlled release topiramate, without decreasing total drug exposure defined by the area under the concentration-time curve (AUC), and
- wherein the second dosage form is administered to the subject daily for at least 2 years, thereby effecting weight loss.
Dependencies are inferred from the claim text.