Claims for Patent: 10,226,423

Summary for Patent: 10,226,423

Title:	Colchicine drug-to-drug interactions
Abstract:	The use of oral colchicine solutions in combination with other therapeutics, while minimizing toxic drug to drug interactions are described herein. Related compositions are also provided.
Inventor(s):	Muni; Indu (North Reading, MA), Vishnupad; Naomi (Reading, MA)
Assignee:	RxOMEG Therapeutics LLC (Woburn, MA)
Application Number:	15/848,498
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,226,423
Patent Claims:	1. A method of treating a colchicine sensitive disorder, comprising orally co-administering a liquid colchicine solution and a CYP3A4 inhibitor to a human subject having a colchicine sensitive disorder in an effective amount to treat the disorder, wherein the liquid colchicine solution comprises a concentration of colchicine of 0.01-1.0 mg/ml, 0.1-0.3% w/v of anhydrous citric acid, 0.8-1.6% w/v of dibasic sodium phosphate heptahydrate, 0.1-0.2% w/v of a thickening agent, a preservative, and water. 2. The method of claim 1, wherein the CYP3A4 inhibitor is a strong CYP3A4 inhibitor. 3. The method of claim 1, wherein the strong CYP3A4 inhibitor is posaconazole. 4. The method of claim 3, wherein the dose of posaconazole is 300-600 mg/dose/day. 5. The method of claim 3, wherein the dose of the liquid colchicine solution is reduced to 2.5 mL or lower once or twice a day when coadministered with posaconazole. 6. The method of claim 3, wherein there is a 2-6 fold increase in colchicine blood levels when posaconazole is co-administered with liquid colchicine solution. 7. The method of claim 1, wherein the CYP3A4 inhibitor is a weak CYP3A4 inhibitor. 8. The method of claim 7, wherein weak CYP3A4 inhibitor is amlodipine besylate. 9. The method of claim 8, wherein the dose of amlodipine besylate is 5-10 mg/dose/day. 10. The method of claim 8, wherein there is no significant effect on colchicine blood levels when liquid colchicine solution is taken in conjunction with amlodipine besylate. 11. The method of claim 1, wherein the CYP3A4 inhibitor is a moderate CYP3A4 inhibitor. 12. The method of claim 11, wherein moderate CYP3A4 inhibitor is ciprofloxacin hydrochloride. 13. The method of claim 12 wherein the dose of ciprofloxacin hydrochloride is 20-750 mg/dose/day. 14. The method of claim 12, wherein there is no significant effect on colchicine blood levels when liquid colchicine solution is taken in conjunction with ciprofloxacin hydrochloride. 15. The method of claim 1, wherein the dose of colchicine is 0.5-1.2 mg/dose/day.