Claims for Patent: 10,660,904

Summary for Patent: 10,660,904

Title:	Optimizing mifepristone levels for cushing's patients
Abstract:	The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.
Inventor(s):	Belanoff; Joseph (Woodside, CA), Gross; Coleman (Menlo Park, CA)
Assignee:	Corcept Therapeutics, Inc. (Menlo Park, CA)
Application Number:	16/219,496
Patent Claims:	1. A method of treating hypercortisolism in a patient, with the proviso that the patient is not already suffering from a condition indicated for treatment with mifepristone, the method comprising: administering a daily dose of 300 milligrams per day (mg/day) of mifepristone to said patient for at least 7 days; then, if the patient's plasma mifepristone trough level is less than 2200 ng/mL, increasing the daily dose amount of mifepristone to 600 mg/day, or, continuing administration of said 300 mg daily dose of mifepristone if said plasma mifepristone trough level is equal to or greater than 2200 ng/mL; and, when said daily dose of mifepristone has been increased to 600 mg/day, administering said daily dose of 600 mg/day of mifepristone to said patient for at least 7 days, and then, if the patient's plasma mifepristone trough level is less than 2200 ng/mL, increasing the daily dose amount of mifepristone to 900 mg/day, or continuing administration of said 600 mg daily dose of mifepristone if said plasma mifepristone trough level is equal to or greater than 2200 ng/mL; and, when said daily dose of mifepristone has been increased to 900 mg/day, administering said daily dose of 900 mg/day of mifepristone to said patient for at least 7 days, and then, if the patient's plasma mifepristone trough level is less than 2200 ng/mL, increasing the daily dose amount of mifepristone to 1200 mg/day, or continuing administration of said 900 mg daily dose of mifepristone if said plasma mifepristone trough level is equal to or greater than 2200 ng/mL; thereby treating hypercortisolism in the patient. 2. The method of claim 1, wherein said daily doses of mifepristone are administered orally. 3. The method of claim 1, wherein said daily dose is not increased more frequently than once every four weeks. 4. The method of claim 1, wherein the patient is treated with 28 or more daily doses of mifepristone over a period of 28 or more days. 5. The method of claim 1, wherein the patient is treated with daily doses of mifepristone for up to six months. 6. The method of claim 1, wherein the patient suffers from ACTH dependent Cushing's syndrome. 7. The method of claim 1, wherein the patient suffers from Cushing's Disease. 8. The method of claim 1, wherein the patient suffers from ectopic Cushing's syndrome. 9. The method of claim 8, wherein said ectopic Cushing's syndrome is caused by ACTH production from a thymoma, a medullary carcinoma of the thyroid, a pheochromocytoma, an islet cell tumor of the pancreas, or a small cell carcinoma of the lung. 10. The method of claim 1, wherein said patient suffers from ACTH independent Cushing's syndrome. 11. The method of claim 10, wherein said patient suffers from ACTH independent Cushing's syndrome caused by an adrenal tumor. 12. The method of claim 11, wherein said adrenal tumor is an adenoma. 13. The method of claim 11, wherein said adrenal tumor is a carcinoma. 14. The method of claim 1, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 15. The method of claim 2, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 16. The method of claim 6, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 17. The method of claim 7, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 18. The method of claim 8, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 19. The method of claim 10, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days. 20. The method of claim 11, wherein: said daily dose of 300 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; if administered, said daily dose of 600 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days; and if administered, said daily dose of 900 milligrams per day (mg/day) of mifepristone is administered to said patient for at least 14 days.