Low dose topiramate/phentermine composition and methods of use thereof
AssigneeVivus, Inc.
InventorsThomas Najarian, Peter Y. Tam, Leland F. Wilson
Life of this patent
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Abstract
A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.
Claims32
A unit dosage form for weight loss for oral administration to a patient having a body mass index of at least 25 kg/m2, comprising a combination of:
- an immediate release phentermine formulation containing a unit dosage of phentermine in the range of 2 mg to 8 mg;
- and
- a controlled release topiramate formulation containing a unit dosage of topiramate in the range of 15 mg to 50 mg,
- wherein the dosage of phentermine in mg/day is about 16% of the dosage of topiramate in mg/day, and
- wherein the controlled release topiramate formulation reaches a 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).
Dependencies are inferred from the claim text.