Optimizing Mifepristone Absorption

Abstract

The present invention provides a method for altering the pharmacokinetics of mifepristone upon oral administration. Mifepristone absorption into the blood is increased upon administration with meals. The method of the invention can benefit patients suffering from conditions including psychiatric illnesses and hormonal disorders.

What is claimed is: 
     
         1 . A method of improving absorption of mifepristone in a patient suffering from a disorder or condition amenable to treatment by mifepristone, wherein said disorder or condition is not Cushing's Syndrome and is not Cushing's disease, the method comprising administering to the patient for at least 7 days an oral dose of mifepristone of 900 milligrams (mg) or 1200 mg per day within about 30 minutes after consuming a meal, such that the pharmacokinetics of mifepristone absorption are altered by increasing the maximum plasma concentration (C max ) and increasing the area under the curve (AUC) as compared to the C max  and AUC that would result from administering mifepristone without food in the fasted state in the absence of the meal, said increase in AUC being at least 44%, and thereby improving mifepristone absorption in the patient. 
     
     
         2 . The method of  claim 1 , wherein the disorder or condition amenable to treatment by mifepristone is selected from obesity, diabetes, cardiovascular disease, hypertension, Syndrome X, depression, psychotic major depression, anxiety, glaucoma, immunodeficiency, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), neurodegeneration, dementia, Alzheimer's disease, Parkinson's disease, Addison's Disease, osteoporosis, frailty, muscle frailty, an inflammatory disease, osteoarthritis, rheumatoid arthritis, asthma, rhinitis, an adrenal function-related ailment, a viral infection, an autoimmune disease, an allergy, wound healing, compulsive behavior, multi-drug resistance, addiction, anorexia, cachexia, a stress disorder, post-traumatic stress syndrome, post-surgical bone fracture, medical catabolism, mild cognitive impairment, antipsychotic induced weight gain, delirium, cognitive impairment in depressed patients, cognitive deterioration in individuals with Down's syndrome, chronic pain, pain associated with gastroesophageal reflux disease, psychosis, psychosis associated with interferon-alpha therapy, postpartum psychosis, postpartum depression, a neurological disorder in a premature infant, and migraine headache. 
     
     
         3 . The method of  claim 1 , wherein the daily oral dose of mifepristone is administered for at least 28 days. 
     
     
         4 . The method of  claim 1 , wherein the mifepristone is administered as a single dose. 
     
     
         5 . The method of  claim 1 , wherein the increase in AUC is between 44% and about 65%. 
     
     
         6 . The method of  claim 1 , wherein the increase in C max  is at least 34%. 
     
     
         7 . The method of  claim 1 , wherein the increase in C max  is between 34% and about 56%. 
     
     
         8 . The method of  claim 5 , wherein the increase in C max  is at least 34%. 
     
     
         9 . The method of  claim 5 , wherein the increase in C max  is between 34% and about 56%. 
     
     
         10 . The method of  claim 1 , wherein the patient is a male. 
     
     
         11 . The method of  claim 1 , wherein the patient is a female. 
     
     
         12 . The method of  claim 1 , wherein the disorder or condition is hypertension. 
     
     
         13 . The method of  claim 1 , wherein the disorder or condition is cardiovascular disease. 
     
     
         14 . The method of  claim 1 , wherein the disorder or condition is depression, or psychotic major depression. 
     
     
         15 . The method of  claim 1 , wherein the disorder or condition is an inflammatory disease. 
     
     
         16 . The method of  claim 1 , wherein the disorder or condition is a stress disorder. 
     
     
         17 . The method of  claim 1 , wherein the disorder or condition is chronic pain, or pain associated with gastroesophageal reflux disease. 
     
     
         18 . The method of  claim 1 , wherein the disorder or condition is postpartum depression. 
     
     
         19 . The method of  claim 1 , wherein the disorder or condition is psychosis. 
     
     
         20 . The method of  claim 19 , wherein the disorder or condition is psychosis associated with interferon-alpha therapy or postpartum psychosis.