Claims for Patent: 7,056,890

Summary for Patent: 7,056,890

Title:	Combination therapy for effecting weight loss and treating obesity
Abstract:	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.
Inventor(s):	Najarian; Thomas (Belmont, MA)
Assignee:	VIVUS, Inc. (Mountain View, CA)
Application Number:	10/454,368
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,056,890
Patent Claims:	1. A pharmaceutical composition comprising about 50 mg to 250 mg topiramate and about 5 mg to about 15 mg phentermine. 2. The composition of claim 1, comprising about 100 mg to 250 mg topiramate. 3. The composition of claim 2, comprising about 100 mg to 200 mg topiramate. 4. The composition of claim 1, comprising a dosage form that provides immediate release of the phentermine and controlled release of the topiramate. 5. The composition of claim 4, wherein the dosage form comprises a core containing the topiramate and a coating containing the phentermine. 6. The composition of claim 4, wherein the dosage form provides for delayed release of the topiramate. 7. The composition of claim 6, wherein the dosage form additionally provides for sustained release of the topiramate. 8. A method for effecting weight loss in a subject comprising administering to the subject a maintenance dose of topiramate in the range of about 50 mg to 250 mg daily and a daily dose of phentermine in the range of about 5 mg to 15 mg. 9. The method of claim 8, wherein the maintenance dose of topiramate is in the range of about 100 to 250 mg daily. 10. The method of claim 8, wherein the maintenance dose of topiramate is in the range of about 100 to 200 mg daily. 11. The method of claim 8, wherein the subject is overweight. 12. The method of claim 8, wherein the subject is obese. 13. The method of claim 8, wherein the subject is neither overweight nor obese. 14. The method of claim 8, wherein the phentermine and the topiramate are administered separately. 15. The method of claim 14, wherein the phentermine and the topiramate are administered at different times of the day. 16. The method of claim 15, wherein the phentermine is administered in the morning and the topiramate is administered at least once later in the day. 17. The method of claim 8, wherein the phentermine is contained in an immediate release dosage form. 18. The method of claim 17, wherein the topiramate is contained in an immediate release dosage form or a controlled release dosage form. 19. The method of claim 18, wherein the topiramate is contained in a controlled release dosage form. 20. The method of claim 19, wherein the controlled release dosage form is a delayed release dosage form. 21. The method of claim 19, wherein the controlled release dosage form is a sustained release dosage form. 22. The method of claim 8, wherein the daily dose of phentermine is about 15 mg per day. 23. The method of claim 8, wherein the phentermine and the topiramate are administered orally. 24. The method of claim 8, wherein the phentermine and the topiramate are administered transdermally. 25. The method of claim 8, wherein the phentermine and the topiramate are administered by injection. 26. The method of claim 8, wherein the phentermine and the topiramate are administered simultaneously. 27. The method of claim 26, wherein the phentermine and the topiramate are contained in a single pharmaceutical formulation. 28. The method of claim 27, wherein the pharmaceutical formulation contains a unit dosage of phentermine and a unit dosage of topiramate. 29. The method of claim 28, wherein the unit dosages are unit daily dosages, such that the formulation is administered once daily. 30. The method of claim 27, wherein the formulation provides for immediate release of the phentermine and controlled release of the topiramate. 31. The method of claim 30, wherein the formulation is composed of an oral dosage form that comprises a core containing the topiramate and a coating containing the phentermine. 32. The method of claim 30, wherein the controlled release formulation provides for delayed release of the topiramate. 33. The method of claim 32, wherein the controlled release formulation additionally provides for sustained release of the topiramate, such that a physiologically effective blood level of topiramate is sustained over an extended time period. 34. The method of claim 30, wherein the controlled release formulation provides for sustained release of the topiramate, such that a physiologically effective blood level of topiramate is sustained over an extended time period. 35. The method of claim 30, wherein the controlled release formulation is composed of granules, hydrogels, matrix formulations, and combinations thereof. 36. The method of claim 30, wherein the controlled release formulation comprises about 5 mg to about 15 mg phentermine and about 100 mg to 200 mg topiramate. 37. The method of claim 30, further including a barrier between the core and the coating to limit drug release from the core. 38. A method for effecting weight loss in a subject, comprising administering to the subject: (a) a daily dose of phentermine in the range of about 5 mg to 15 mg; and (b) a therapeutically effective amount of topiramate that is gradually increased, over an extended time period, from an initial daily dosage up to a final daily dosage suitable for continued maintenance therapy, wherein the final daily dosage is in the range of about 50 mg to 250 mg. 39. The method of claim 38, wherein the initial daily dosage is about 25 mg. 40. The method of claim 38, wherein the final daily dosage is in the range of about 100 mg to 250 mg. 41. The method of claim 40, wherein the final daily dosage is in the range of about 100 mg to 200 mg. 42. The method of claim 39, wherein the final daily dosage is in the range of about 100 mg to 250 mg. 43. The method of claim 42, wherein the final daily dosage is in the range of about 100 mg to 200 mg. 44. The method of claim 38, wherein the therapeutically effective amount of topiramate administered to the subject is increased on an approximately weekly basis over said extended time period. 45. The method of claim 44, wherein the topiramate is administered at an initial daily dosage of 25 mg 5 7 days, at 50 mg daily for the next 5 7 days, at 100 mg daily for the next 6 8 days, and about 100 mg to 150 mg daily for the next 20 26 days, and then at a maintenance dose of 100 mg to 200 mg daily. 46. A method of treating at least one side effect associated with obesity comprising administering to an obese subject a therapeutically effective daily dose of topiramate in the range of about 50 mg to 250 mg daily and a therapeutically effective daily dose of phentermine in the range of about 5 mg to 15 mg, such that at least one side effect associated with obesity is effectively treated. 47. The method of claim 46, wherein the daily dose of topiramate is in the range of about 100 to 250 mg. 48. The method of claim 47, wherein the daily dose of topiramate is in the range of about 100 mg to 200 mg. 49. A kit comprising a packaged combination of phentermine and topiramate, and instructions for a patient to carry out drug administration to achieve weight loss, wherein the phentermine and topiramate are present in separate and discrete dosage forms, and further wherein the topiramate dosage forms each contain about 50 mg to 250 mg topiramate and the phentermine dosage forms each contain about 5 mg to 15 mg phentermine. 50. The kit of claim 49, wherein the topiramate dosage forms each contain about 100 mg to 250 mg topiramate. 51. The kit of claim 50, wherein the topiramate dosage forms each contain about 100 mg to 200 mg topiramate. 52. A kit comprising a sealed package of controlled release dosage forms each containing about 50 mg to 250 mg topiramate and about 5 mg to 15 mg phentermine, wherein the dosage forms provide for immediate release of the phentermine and delayed release of the topiramate. 53. The kit of claim 52, wherein the dosage forms each contain about 100 mg to 250 mg topiramate. 54. The kit of claim 53, wherein the dosage forms each contain about 100 mg to 200 mg topiramate.