Drug implants containing enzalutamide and methods of use thereof
Provided herein are drug implants comprising enzalutamide for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and enzalutamide disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may be used for the treatment of a proliferative disease of the prostate.
1 . A method of treating a proliferative disease of a prostate in a subject, the method comprising implanting one or more drug implants into a tissue of the subject, wherein each of the one or more drug implants comprises a non-biodegradable polymer matrix and enzalutamide, and wherein the enzalutamide is present within the one or more drug implants at an amount from about 10 w/w % to 80 w/w %, thereby treating the proliferative disease of the prostate in the subject.
2 . The method of claim 1 , wherein the proliferative disease of the prostate is prostate cancer or benign prostatic hyperplasia.
3 . The method of claim 2 , wherein the prostate cancer is castration-sensitive prostate cancer or non-metastatic castration-resistant prostate cancer.
4 . The method of claim 1 , wherein the tissue is prostate tissue or a tissue adjacent the prostate.
5 . The method of claim 1 , wherein the enzalutamide is dispersed within the non-biodegradable polymer matrix.
6 . The method of claim 1 , wherein the one or more drug implants delivers a therapeutically effective amount of the enzalutamide to the prostate for at least 6 months.
7 . The method of claim 1 , wherein the implanting comprises deploying each of the one or more drug implants to the tissue through a lumen of a needle or a catheter.
8 . The method of claim 1 , wherein the implanting occurs via transperineal administration.
9 . The method of claim 8 , wherein the transperineal administration comprises using a template guided needle.
10 . The method of claim 1 , wherein a total dose of enzalutamide administered to the subject is less than a total dose of enzalutamide when administered to a subject by oral administration.
11 . The method of claim 1 , wherein a total dose of enzalutamide administered to the subject is less than 100 mg over a period of 6 months.
12 . The method of claim 1 , wherein the one or more drug implants is 2 to 16 drug implants.
13 . The method of claim 1 , wherein the non-biodegradable polymer matrix comprises silicone.
14 . The method of claim 13 , wherein the silicone is an acetoxy-cured silicone.
15 . The method of claim 1 , wherein the non-biodegradable polymer matrix comprises a thermoplastic polyurethane or poly(ethylene vinyl acetate).
16 . The method of claim 4 , further comprising, removing the prostate or a portion of the prostate from the subject.
17 . The method of claim 16 , wherein the one or more drug implants are implanted into the prostate tissue or the tissue adjacent the prostate for at least one week prior to the removing the prostate or the portion of the prostate from the subject.