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(12) United States Patent (10) Patent No.: US 8.598,149 B2 Belanoff (45) Date of Patent: Dec

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(12) United States Patent (10) Patent No.: US 8.598,149 B2 Belanoff (45) Date of Patent: Dec US008598149B2 (12) United States Patent (10) Patent No.: US 8.598,149 B2 Belanoff (45) Date of Patent: Dec. 3, 2013 (54) OPTIMIZING MIFEPRISTONE LEVELS IN (58) Field of Classification Search PLASMA SERUM OF PATIENTS SUFFERING USPC .................................................. 514/182, 178 FROMMENTAL DISORDERS TREATABLE See application file for complete search history. WITH GLUCOCORTICOD RECEPTOR (56) References Cited ANTAGONSTS U.S. PATENT DOCUMENTS (75) Inventor: Joseph K. Belanoff, Woodside, CA (US) 6,964,953 B2 * 1 1/2005 Belanoff ....................... 514,178 (73) Assignee: Corcept Therapeutics, Inc., Menlo OTHER PUBLICATIONS Park, CA (US) Sarkar, European Journal of Obstetrics and Gynecology and Repro (*) Notice: Subject to any disclaimer, the term of this ductive Biology, 2002: 101: 113-120.* patent is extended or adjusted under 35 Medical Encyclopedia of Medline (http:// http://www.nlm.nih.gov/ U.S.C. 154(b) by 866 days. medlineplus/ency/article/003430.htm, Oct. 2005.* (21) Appl. No.: 12/199,114 * cited by examiner Primary Examiner — San-Ming Hui (22) Filed: Aug. 27, 2008 (74) Attorney, Agent, or Firm — Kilpatrick Townsend & (65) Prior Publication Data Stockton LLP. US 2009/OO62248A1 Mar. 5, 2009 (57) ABSTRACT The present invention provides a method for optimizing lev els of mifepristone in a patient Suffering from a mental dis Related U.S. Application Data order amenable to treatment by mifepristone. The method comprises the steps of treating the patient with seven or more (60) Provisional application No. 60/969,027, filed on Aug. daily doses of mifepristone over a period of seven or more 30, 2007. days; testing the serum levels of the patient to determine (51) Int. Cl. whether the blood levels of mifepristone are greater than 1300 A6 IK3I/56 (2006.01) ng/mL, and adjusting the daily dose of the patient to achieve (52) U.S. Cl. mifepristone blood levels greater than 1300 ng/mL. USPC ........................................... 514/178; 514/182 7 Claims, 6 Drawing Sheets BPRS PSS-Days 7 and 56 Response 40 35 - 359% % of patients 30 - 26% who have at 25 - east 50% reduction from baseline 20 - in BPRS PSS SCOres at 15 - days 7 and 56 10 - 5 H 0 - Corlux Placebo nE 443 nF 281 U.S. Patent Dec. 3, 2013 Sheet 1 of 6 US 8.598,149 B2 SaeidgSÁeq–SSdpueJ.?suodsæN99 07 98 U.S. Patent SaeidgSSdSÁed–pueZ?suodsæN99 3.In?!A'z U.S. Patent Dec. 3, 2013 Sheet 4 of 6 US 8.598,149 B2 SaeidaSSd—sesuodsex.qeSÁeqJ.pue99 0/ 09 09 07 09 0Z 0!, 0 seuoosqesÁep pue199 3.InáI*# U.S. Patent SaeidgSSd–S?eCI/pue99?suodse?) U.S. Patent SaeidaSSdSÁed–pue/99ºsuodse?) US 8.598,149 B2 1. 2 OPTIMIZING MIFEPRSTONE LEVELS IN In a second embodiment, the present invention provides a PLASMA SERUM OF PATIENTS SUFFERING kit for treating a mental disorder amenable to treatment by FROMMENTAL DISORDERS TREATABLE mifepristone, the kit comprising: seven daily doses of mife WITH GLUCOCORTICOD RECEPTOR pristone; and a plasma sampling collection device Suitable for ANTAGONSTS detecting mifepristone serum levels. CROSS-REFERENCES TO RELATED BRIEF DESCRIPTION OF THE DRAWINGS APPLICATIONS FIG. 1 shows a comparison of patients receiving CorluX vs. This application claims priority to U.S. Provisional Appli 10 placebo on primary endpoint (OC) for all studies. Of the cation No. 60/969,027, filed Aug. 30, 2007, the disclosure of patients receiving Corlux, 35% of the patients showed at least which is incorporated herein in its entirety. a 50% reduction from baseline in BPRS PSS scores at days 7 and 56, versus 26% of patients receiving the placebo. STATEMENT AS TO RIGHTS TO INVENTIONS FIG. 2 shows a comparison of patients with plasma lev MADE UNDER FEDERALLY SPONSORED 15 els 1357 ng/mL vs.<1357 ng/mL vs. placebo (OC) for all RESEARCH AND DEVELOPMENT studies. Of the patients having plasma levels of greater than 1357 ng/mL, 40% of the patients showed at least a 50% NOTAPPLICABLE reduction from baseline in BPRSPSS scores at days 7 and 56, versus 27% of patients having plasma levels of less than 1357 REFERENCE TO A “SEQUENCE LISTING. A ng/mL and 26% of patients receiving the placebo. TABLE, ORACOMPUTER PROGRAM LISTING FIG. 3 shows a comparison of patients with plasma lev APPENDIX SUBMITTED ON A COMPACT DISK els 1661 ng/ml vs. placebo (OC) for all studies. Of the patients having plasma levels of greater than 1661 ng/mL, NOTAPPLICABLE 44% of the patients showed at least a 50% reduction from 25 baseline in BPRSPSS scores at days 7 and 56, versus 29% of BACKGROUND OF THE INVENTION patients having plasma levels of less than 1661 ng/mL and 26% of patients receiving the placebo. It has been Surprisingly discovered that administration of FIG. 4 shows a comparison of patients receiving CorluX vs. the same dose of mifepristone can produce widely varying placebo on primary endpoint (OC) for the 1200 mg group. Of blood serum levels in different patients. The varied blood 30 the patients receiving the 1200 mg dose of Corlux, 47% of the serum levels can result in some patients not receiving an patients showed at least a 50% reduction from baseline in efficacious dose of mifepristone. For the same dose of mife BPRS PSS scores at days 7 and 56, versus 34% of patients pristone, the blood serum levels can differ by as much as receiving the placebo. 800% from one patient to another. Thus, a method for ensur FIG. 5 shows a comparison of patients with plasma lev ing that the blood serum levels of mifepristone remain in an 35 els 1357 ng/ml vs. placebo (OC) for the 1200 mg group. Of efficacious and safe range is needed. the patients in the 1200 mg group having plasma levels of greater than 1357 ng/mL, 54% of the patients showed at least BRIEF SUMMARY OF THE INVENTION a 50% reduction from baseline in BPRS PSS scores at days 7 and 56, versus 31% of patients having plasma levels of less In one embodiment, the present invention provides a 40 than 1357 ng/mL and 34% of patients receiving the placebo. method for optimizing levels of mifepristone in a patient FIG. 6 shows a comparison of patients with plasma lev suffering from a mental disorder amenable to treatment by els 1661 ng/ml vs. placebo (OC) for the 1200 mg group. Of mifepristone, the method comprising: treating the patient the patients in the 1200 mg group having plasma levels of with seven or more daily doses of mifepristone over a period greater than 1661 ng/mL, 58% of the patients showed at least of seven or more days; testing the serum levels of the patient 45 a 50% reduction from baseline in BPRS PSS scores at days 7 to determine whether the blood levels of mifepristone are and 56, versus 39% of patients having plasma levels of less greater than 1300 ng/mL, and adjusting the daily dose of the than 1661 ng/mL and 34% of patients receiving the placebo. patient to achieve mifepristone blood levels greater than 1300 ng/mL. DETAILED DESCRIPTION OF THE INVENTION In some embodiments, the mental disorder is a member 50 selected from the group consisting of a stress disorder, I. Introduction delirium, mild cognitive impairment (MCI), dementia, psy chosis and psychotic major depression. In other embodi Administration of the same dose of mifepristone can pro ments, the stress disorder is a member selected from the group duce widely varying mifepristone blood serum levels in dif consisting of Acute Stress Disorder, Post-Traumatic Stress 55 ferent patients. For the same dose, the blood serum levels can Disorder and Brief Psychotic Disorder with Marked Stressor differ by as much as 800% from one patient to another. For (s). those patients with lower blood serum levels, the effective In another embodiment, each of the seven or more daily ness of mifepristone treatment can Suffer significantly. The doses of mifepristone are administered orally. In other present invention provides a method for optimizing the blood embodiments, the patient is treated with 28 or more daily 60 serum levels of mifepristone so that the blood serum levels doses over a period of 28 or more days. remain in an efficacious range and the patient receives the In a further embodiment, the testing is performed by a necessary treatment. plasma sampling collection device Suitable for detecting The method of the present invention optimizes blood mifepristone serum levels. serum levels of mifepristone in a patient Suffering from a In other embodiments, the adjusting step comprises 65 mental disorder amenable to treatment by mifepristone by increasing the daily dose of the patient to achieve mifepris first treating the patient with mifepristone. The treatment can tone blood levels greater than 1300 ng/mL. be for any appropriate period of time. Such as seven or more US 8.598,149 B2 3 4 daily doses over a period of seven or more days. Following (see, e.g., Hughes et al., Brit. J. Psychiat. 140:566-572, 1982) treatment for an appropriate period of time, the serum levels and further characterized by memory impairment, but not of the patient are tested to determine whether the blood levels impaired function in other cognitive domains. Memory of mifepristone are greater than 1300 ng/mL. The daily dose impairment is preferably measured using tests Such as a of the patient is then adjusted in order to achieve mifepristone “paragraph test'. A patient diagnosed with MCI often exhib blood levels of greater than 1300 ng/mL. its impaired delayed recall performance. MCI is typically associated with aging and generally occurs in patients who II. Definitions are 45 years of age or older.
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