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Last Updated: September 21, 2021

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Claims for Patent: 9,943,526


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Summary for Patent: 9,943,526
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:15/133,791
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,943,526
Patent Claims: 1. A method for treating a patient suffering from Cushing's syndrome, the method comprising: A) treating said patient with seven or more daily doses of mifepristone over a period of seven or more days, wherein each of said daily doses contains an initial amount of mifepristone; B) testing the plasma mifepristone levels of the patient; then C) if the plasma mifepristone levels of the patient are greater than 1631 ng/mL, continuing to treat the patient with said daily doses of mifepristone; or D) if the plasma mifepristone levels of the patient are less than or equal to 1631 ng/mL, continuing to treat the patient with daily doses of mifepristone, wherein each daily dose contains an amount of mifepristone that is greater than said initial amount of mifepristone; and E) repeating step B) and then step C) or step D); thereby adjusting the daily dose of the patient to achieve mifepristone plasma levels greater than 1631 ng/mL, with the proviso that the patient is not already suffering from a condition indicated for treatment with mifepristone, whereby mifepristone treatment optimized to achieve mifepristone plasma levels greater than 1631 ng/mL is provided to the patient suffering from Cushing's syndrome.

2. The method of claim 1, wherein each of the seven or more daily doses of mifepristone are administered orally.

3. The method of claim 1, wherein the initial daily dose of mifepristone contains at least 300 mg of mifepristone.

4. The method of claim 1, wherein the initial daily dose of mifepristone contains at least 600 mg of mifepristone.

5. The method of claim 1, wherein the initial daily dose of mifepristone contains at least 900 mg of mifepristone.

6. The method of claim 1, wherein the initial daily dose of mifepristone contains at least 1200 mg of mifepristone.

7. The method of claim 1, wherein the patient is treated with 28 or more daily doses over a period of 28 or more days.

8. The method of claim 1, wherein the testing is performed on a sample collected by a plasma sampling collection device and mifepristone levels in the sample are detected using a device suitable for detecting mifepristone plasma levels.

9. The method of claim 1, wherein mifepristone plasma levels greater than 1631 ng/mL are achieved, wherein the adjusting step comprises further adjusting the daily dose of the patient to maintain mifepristone plasma levels greater than 1631 ng/mL for up to six months.

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