CORTICOTROPIN RELEASING FACTOR RECEPTOR ANTAGONISTS
The present invention provides novel pharmaceutical compositions comprising -(4-Chloro-2-(morpholin-4-yl)thiazol-5-yl)-7-(1-ethylpropyl)-2,5-dimethylpyrazolo(1,5-a)pyrimidine and methods of using the same for the treatment of Congenital adrenal hyperplasia (CAH).
1 .- 180 . (canceled)
181 . A method of treating congenital adrenal hyperplasia (CAH), hyperandrogenic symptoms, menstrual irregularity, ovulatory dysfunction or infertility in a subject, comprising:
administering Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, at a dose between about 50 mg/day and about 800 mg/day.
182 . The method of claim 181 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 200 mg/day.
183 . The method of claim 181 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 200 mg/day.
184 . The method of claim 181 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 100 mg/day.
185 . The method of claim 181 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 75 mg/day.
186 . The method of claim 181 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 50 mg/day.
187 . The method of claim 181 , the pharmaceutical composition is administered once a day.
188 . The method of claim 181 , further comprising administering a glucocorticoid.
189 . The method of claim 188 , wherein the amount of glucocorticoid is reduced compared to a previously administered dose of the glucocorticoid.
190 . The method of claim 189 , wherein the reduced amount of glucocorticoid is a reduced daily dose of the glucocorticoid and the previously administered dose of the glucocorticoid is a previously administered daily dose of the glucocorticoid.
191 . The method of claim 189 , wherein the amount of glucocorticoid is reduced from a supraphysiologic amount to a physiologic amount.
192 . The method of claim 189 , wherein the amount of glucocorticoid is reduced by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.
193 . The method of claim 192 , wherein symptoms associated with high-dose glucocorticoid therapy are reduced, wherein the symptoms associated with high-dose glucocorticoid therapy are obesity, insulin resistance, metabolic abnormalities, hypertension, cardiovascular diseases, or osteoporosis.
194 . The method of claim 188 , wherein the glucocorticoid is beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or triamcinolone.
195 . The method of claim 194 , wherein the glucocorticoid is hydrocortisone.
196 . The method of claim 195 , wherein the hydrocortisone is administered at a dose less than about 10 mg/day.
197 . The method of claim 195 , wherein the hydrocortisone is administered at a dose less than about 5 mg/day.
198 . The method of claim 188 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered concurrently.
199 . The method of claim 188 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially.
200 . The method of claim 199 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 24 hours.
201 . The method of claim 199 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 2 hours.