ONAPRISTONE EXTENDED-RELEASE COMPOSITIONS AND METHODS
Onapristone extended-release formulations and methods of administering onapristone extended-release formulations are provided. Onapristone extended-release formulations provide sufficient therapeutic activity as compared to immediate-release formulations with reduced potential for adverse side effects.
1 . A method of administering onapristone to a patient having cancer comprising administering a pharmaceutical composition comprising onapristone to the subject, wherein the pharmaceutical composition comprises onapristone, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose, silicon dioxide, and magnesium stearate.
2 . The method of claim 1 , wherein the composition comprises about 10 mg to about 50 mg of onapristone.
3 . The method of claim 1 , wherein the composition comprises about 10 mg, about 20 mg, or about 25 mg of onapristone.
4 . The method of claim 1 , wherein the pharmaceutical composition is administered twice per day.
5 . The method of claim 1 , wherein the onapristone is at least about 98% pure.
6 . The method of claim 1 , wherein the cancer expresses the progesterone receptor.
7 . The method of claim 1 , wherein the cancer is selected from the group consisting of breast, prostate, ovarian, and uterine cancer.
8 . The method of claim 1 , wherein the cancer is ovarian cancer.
9 . The method of claim 1 , wherein the cancer is breast cancer.
10 . The method of claim 1 , wherein the cancer is uterine cancer.
11 . The method of claim 1 , wherein the cancer is prostate cancer.
12 . The method of claim 1 , wherein the composition consists essentially of onapristone, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose, silicon dioxide, and magnesium stearate.
13 . The method of claim 1 , wherein the composition consists of onapristone, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose, silicon dioxide, and magnesium stearate.
14 . A method of treating ovarian, breast or uterine cancer in a subject, the method comprising administering to the subject a pharmaceutical composition comprising onapristone, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose, silicon dioxide, and magnesium stearate.
15 . The method of claim 14 , wherein the cancer is ovarian cancer.
16 . The method of claim 14 , wherein the cancer is uterine cancer.
17 . The method of claim 14 , wherein the cancer is breast cancer.