COMBINATION THERAPY FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY
The present invention features a novel therapy for effecting weight loss which involves treating a subject with a sympathomimetic agent (e.g., phentermine or a phentermine-like drug) in combination with an anticonvulsant sulfamate derivative (e.g., topiramate) such that the subject experiences weight loss. The combination methods of the present invention also are effective against symptoms associated with Syndrome X. The invention also features pharmaceutical compositions and kits for use in the practice of these novel therapies.
1 . A pharmaceutical composition formulated for oral administration comprising
25 mg to 100 mg of topiramate, formulated for controlled release, and
5 mg to 15 mg of phentermine, formulated for immediate release.
2 . The pharmaceutical composition of claim 1 comprising
25 mg to 50 mg of topiramate, formulated for controlled release, and
5 mg to 8 mg of phentermine, formulated for immediate release.
3 . A method of effecting weight loss a subject need thereof by administering a pharmaceutical composition formulated for oral administration comprising
25 mg to 100 mg of topiramate, formulated for controlled release, and
5 mg to 15 mg of phentermine, formulated for immediate release.
4 . The method of claim 3 comprising
25 mg to 50 mg of topiramate, formulated for controlled release, and
5 mg to 8 mg of phentermine, formulated for immediate release.
5 . The pharmaceutical composition of claim 1 , wherein the composition further comprises a pharmaceutically acceptable carrier.
6 . The pharmaceutical composition of claim 1 , wherein formulated for controlled release is formulated for delayed release.
7 . The pharmaceutical composition of claim 6 , wherein delayed release is delaying the release of topiramate for at least 4 hours following the release of phentermine.
8 . The pharmaceutical composition of claim 1 , wherein formulated for controlled release is formulated for sustained release.
9 . The pharmaceutical composition of claim 8 , wherein sustained release is providing topiramate over at least a 4 hour time period.
10 . The pharmaceutical composition of claim 1 , wherein the composition is a tablet, capsule, troche, suspension, syrup or wafer.
11 . The pharmaceutical composition of claim 10 , wherein the tablet, capsule or pill comprises a topiramate core in association with a layer of phentermine.
12 . The pharmaceutical composition of claim 10 , wherein the tablet, capsule or pill comprises at least a first layer comprising phentermine and at least a second layer comprising topiramate.
13 . The pharmaceutical composition of claim 12 , wherein the at least first layer is the outer most layer of the tablet, capsule or pill.
14 . The pharmaceutical composition of claim 12 , wherein the at least second layer is the core of the tablet, capsule or pill.
15 . The method of claim 3 , wherein the composition is administered for 5 to 9 months.
16 . The method of claim 3 , wherein the composition is administered for 12 to 18 months.
17 . The method of claim 3 , wherein the composition is administered for up to 18 months.
18 . The method of claim 3 , wherein the composition is administered until the subject has achieved a weight loss of at least 5% compared to the subject's weight prior to administration of the composition.
19 . The method of claim 18 , wherein the composition is administered until the subject has achieved a weight loss of 5-10%.
20 . The method of claim 3 , wherein the composition is administered until the subject has achieved a weight loss of at least 10% compared to the subject's weight prior to administration of the composition.
21 - 23 . (canceled)