Claims for Patent: 9,675,613

Summary for Patent: 9,675,613

Title:	Methods of colchicine administration
Abstract:	The invention provides improved methods for coadministration of colchicine with drugs metabolized by CYP3A4 (anciently referred to as cytochrome P450 isozyme 3A4) or the P-glycoprotein transporter, but not both. The method enables non-toxic coadministration of colchicine and the second drug at their ordinary levels safely and effectively without reducing the dose or frequency for either drug.
Inventor(s):	Ducharme; Murray (St. Laurent, CA)
Assignee:	Hikma Pharmaceuticals LLC (JO)
Application Number:	14/511,703
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,675,613
Patent Claims:	1. A method of administering colchicine to a patient in need thereof while concomitantly administering a second drug that is an inhibitor of P-glycoprotein 1 (P-gp) but is not an inhibitor of the cytochrome P450 3A4 isozyme (CYP3A4), wherein the second drug is propafenone, wherein the method comprises: (a) administering to the patient a fixed maintenance dose of colchicine in an amount of from about 0.6 to about 1.2 mg/day, for a maintenance period of a plurality of days, without administering propafenone; (b) after step (a), administering to the patient one or more therapeutically effective doses of the second drug; and (c) concomitantly with step (b), administering to the patient the fixed maintenance dose of colchicine of step (a) without dose reduction. 2. The method of claim 1, wherein the second drug is administered at a dose of from 225 mg/day to 450 mg/day. 3. The method of claim 1, wherein the fixed maintenance dose of colchicine is 0.6 mg/day. 4. The method of claim 1, wherein the fixed maintenance dose of colchicine is 1.2 mg/day. 5. The method of claim 1, wherein the plurality of days comprises at least 7 days. 6. The method of claim 1, wherein step (b) is performed after step (a). 7. The method of claim 1, wherein the colchicine is administered to the patient for the prevention of gout flares. 8. A method of preventing gout flares in a patient in need thereof comprising administering colchicine while concomitantly administering a second drug that is an inhibitor of P-glycoprotein 1 (P-gp) but is not an inhibitor of the cytochrome P450 3A4 isozyme (CYP3A4), wherein the second drug is propafenone, wherein the method comprises: (a) administering to the patient a fixed maintenance dose of colchicine in an amount of from about 0.6 to about 1.2 mg/day, for a maintenance period of a plurality of days, without administering propafenone; (b) after step (a), administering to the patient one or more therapeutically effective doses of the second drug; and (c) concomitantly with step (b), administering to the patient the fixed maintenance dose of colchicine of step (a) without dose reduction. 9. The method of claim 8, wherein the second drug is administered at a dose of from 225 mg/day to 450 mg/day. 10. The method of claim 8, wherein the fixed maintenance dose of colchicine is 0.6 mg/day. 11. The method of claim 8, wherein the fixed maintenance dose of colchicine is 1.2 mg/day. 12. The method of claim 8, wherein the plurality of days comprises at least 7 days. 13. The method of claim 8, wherein step (b) is performed after step (a).