COMPOSITIONS COMPRISING ATICAPRANT
The present disclosure relates to compositions, including oral compositions in the form of tablets, comprising aticaprant and methods of using the same.
1 . A method of treating major depressive disorder in a human patient, comprising administering a pharmaceutical composition comprising aticaprant and one or more pharmaceutically acceptable excipients to the human patient, wherein the patient had a previous inadequate response to other antidepressant therapy and wherein the pharmaceutical composition is administered orally once daily.
2 . The method of claim 1 , wherein the pharmaceutical composition is administered with or without food.
3 . The method of claim 1 , wherein the pharmaceutical composition is an oral tablet.
4 . The method of claim 1 , wherein the pharmaceutical composition comprises about 5 mg to about 10 mg aticaprant.
5 . The method of claim 1 , wherein the pharmaceutical composition comprises about 10 mg aticaprant.
6 . The method of claim 3 , wherein the pharmaceutical composition comprises about 5 mg to about 10 mg aticaprant.
7 . The method of claim 3 , wherein the pharmaceutical composition comprises about 10 mg aticaprant.
8 . The method of claim 1 , wherein the other antidepressant therapy comprised one or more antidepressants.
9 . The method of claim 8 , wherein the one or more antidepressants comprised a SSRI, SNRI, or a combination thereof.
10 . The method of claim 1 , wherein the aticaprant is S-aticaprant.
11 . The method of claim 1 , wherein the aticaprant is crystalline aticaprant.
12 . The method of claim 1 , further comprising treatment with an effective amount of one or more antidepressants.
13 . The method of claim 12 , wherein the one or more antidepressants is a SSRI, SNRT, or combination thereof.
14 . The method of claim 1 , wherein the patient has anhedonia.
15 . The method of claim 1 , wherein the pharmaceutical composition comprises one or more of: a filler, a disintegrant, a glidant, a lubricant, a binder, and a coloring agent.
16 . The method of claim 15 , wherein the filler is selected from: microcrystalline cellulose, lactose monohydrate, and silicified microcrystalline cellulose; the disintegrant is croscarmellose sodium; the glidant is silica, colloidal anhydrous; and the lubricant is magnesium stearate.
17 . The method of claim 1 , wherein the pharmaceutical composition comprises between about 0.1% and 90% aticaprant by weight.
18 . The method of claim 1 , wherein the pharmaceutical composition comprises between about 1% to about 10% aticaprant by weight.
19 . The method of claim 1 , wherein the pharmaceutical composition comprises between about 10% and 99.9% filler by weight.
20 . The method of claim 1 , wherein the pharmaceutical composition is a film coated oral tablet, comprising (i) a film coat and (ii) a core tablet, wherein the core tablet comprises about 5% aticaprant by weight, about 88.5% filler by weight, about 5% disintegrant by weight, about 1% glidant by weight, and about 0.5% lubricant by weight.
21 . The method of claim 20 , wherein the film coated oral tablet comprises about 97% core tablet by weight and about 3% film coat by weight.
22 . The method of claim 1 , wherein the pharmaceutical composition is an oral tablet comprising about 10 mg aticaprant, wherein the oral tablet comprises a core tablet of about 200 mg, wherein the core tablet comprises an intragranular and extragranular phase, wherein the intragranular phase comprises about 60 mg microcrystalline cellulose, about 60 mg lactose monohydrate, about 5 mg croscarmellose sodium, and about 1 mg silica, colloidal anhydrous; and wherein the extragranular phase comprises about 57 mg silicified microcrystalline cellulose, about 5 mg croscarmellose sodium, about 1 mg silica, colloidal anhydrous, and about 1 mg magnesium stearate.