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Claims for Patent: 8,415,395

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Claims for Patent: 8,415,395

Title:Colchicine compositions and methods
Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.
Inventor(s): Davis; Matthew W. (Erwinna, PA), Feng; Hengsheng (Cherry Hill, NJ)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:13/451,328
Patent Claims: 1. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after the first administration; the method providing lower incidence of an adverse event in a randomized placebo-controlled study compared to a second method of orally administering 4.8 mg oral colchicine over a period of 6 hours.

2. The method of claim 1, wherein the adverse event is a treatment-emergent gastrointestinal adverse event.

3. The method of claim 2, wherein the treatment-emergent gastrointestinal adverse event is vomiting.

4. The method of claim 2, wherein the treatment-emergent gastrointestinal adverse event is nausea.

5. The method of claim 2, wherein the treatment-emergent gastrointestinal adverse event is diarrhea.

6. The method of claim 5 wherein lower incidence of diarrhea comprises a reduction of at least about 50% reduction from the incidence of diarrhea for the second method.

7. The method of claim 2, wherein the lower incidence is a reduction of at least about 30% from the incidence of the treatment-emergent gastrointestinal adverse event for the second method.

8. The method of claim 7, wherein the reduction is at least about 50% from the incidence of the treatment-emergent gastrointestinal adverse event for the second method.

9. The method of claim 1, wherein the colchicine is in the form of a dosage form containing 0.6 mg colchicine.

10. The method of claim 9, wherein the dosage form is a tablet.

11. The method of claim 10 wherein the tablet is an immediate release tablet.

12. The method of claim 1, wherein the colchicine is administered with or without food.

13. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after the first administration; the method characterized by an incidence of a gastrointestinal adverse event that is not significantly different from incidence of the gastrointestinal adverse event characterizing administration of placebo.

14. The method of claim 13, wherein the gastrointestinal adverse event is diarrhea.

15. The method of claim 13, wherein the gastrointestinal adverse event is nausea.

16. The method of claim 13, wherein the gastrointestinal adverse event is vomiting.

17. The method of claim 13, wherein the colchicine is in the form of a dosage form containing 0.6 mg colchicine.

18. The method of claim 17, wherein the dosage form is a tablet.

19. The method of claim 18 wherein the tablet is an immediate release tablet.

20. The method of claim 13, wherein the colchicine is administered with or without food.
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