US2023157960A1PendingUtilityA1

Onapristone extended-release compositions and methods

70
Assignee: CONTEXT BIOPHARMA INCPriority: Nov 17, 2014Filed: Jan 9, 2023Published: May 25, 2023
Est. expiryNov 17, 2034(~8.3 yrs left)· nominal 20-yr term from priority
Inventors:Alexander ZukiwskiStefan Proniuk
A61K 9/20A61K 9/2054A61K 31/575A61P 35/00A61K 9/48
70
PatentIndex Score
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         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.

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