Solid Pharmaceutical Formulations for Treating Endometriosis, Uterine Fibroids, Polycystic Ovary Syndrome or Adenomyosis

A solid pharmaceutical composition comprising:

• 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid (Compound A) or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable meltable binder in a solid matrix, such as amorphous solid dispersion;
• a pH modifying agent;
• a disintegrant;
• and
• a glidant;
• wherein the pH modifying agent, the disintegrant, and the glidant are outside the solid dispersion.

A solid pharmaceutical composition comprising:

• (a) from about 55% to about 60% by weight of amorphous sodium 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)butanoate;
• (b) from about 4% to about 6% by weight of a pharmaceutically acceptable hydrophilic meltable polymer;
• (c) from about 25% to about 35% by weight of a pH modifying agent;
• (d) from about 4% to about 6% by weight of a disintegrant;
• (e) from about 0.1% to about 2% by weight of a glidant;
• and
• (f) from about 0.5% to about 1.5% by weight of a lubricant.

A method of treating heavy menstrual bleeding and pelvic pain in a woman with symptomatic adenomyosis or non-dominant adenomyosis comprising administering a pharmaceutical composition comprising about 300 mg equivalent of Compound A, wherein said composition includes:

• (a) about 33.2% by weight of sodium 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)butanoate;
• (b) about 16.7% by weight of an alkali metal salt;
• and
• (c) about 51.1% by weight of one or more excipients, wherein the excipients comprises a binder, a water soluble filler, a lubricant, and a film-coating.