RIMEGEPANT FOR CGRP RELATED DISORDERS
Disclosed are methods of treating CGRP related disorders, e.g., migraine, by administering to a patient in need thereof rimegepant or a pharmaceutically acceptable salt thereof. Pharmaceutical compositions comprising rimegepant and kits including the pharmaceutical compositions and instructions are also disclosed.
1 - 21 . (canceled)
22 . A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of rimegepant, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.
23 . The pharmaceutical composition of claim 22 , wherein the rimegepant is in the form of a hemisulfate salt.
24 . The pharmaceutical composition of claim 22 , wherein the rimegepant is in the form of a hemisulfate sesquihydrate salt.
25 . The pharmaceutical composition of claim 22 , further comprising gelatin as a carrier.
26 . The pharmaceutical composition of claim 22 , further comprising mannitol as a filler.
27 . The pharmaceutical composition of claim 22 , comprising from about 70-80 weight % of the rimegepant or a pharmaceutically acceptable salt thereof, about 10-20 weight % fish gelatin, about 10-20 weight % of a filler, and 0.1-5.0 weight % of a flavorant.
28 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is capable of disintegrating or dispersing within an interval selected from 1 to 60 seconds, 1 to 30 seconds, 1 to 10 seconds, and 2 to 8 seconds, after being placed in contact with a fluid.
29 . The pharmaceutical composition of claim 28 , wherein the fluid comprises saliva.
30 . The pharmaceutical composition of claim 22 in the form of a tablet.
31 . The pharmaceutical composition of claim 22 , that provides an AUC 0-t of from about 80-125% of 5000 (hr*ng/mL).
32 . A method of treating migraine in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of rimegepant, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.
33 . The method of claim 32 , wherein the rimegepant is in the form of a hemisulfate salt.
34 . The method of claim 32 , wherein the rimegepant is in the form of a hemisulfate sesquihydrate salt.
35 . The method of claim 32 , wherein the pharmaceutical composition further comprises gelatin as a carrier.
36 . The method of claim 32 , wherein the pharmaceutical composition further comprises mannitol as a filler.
37 . The method of claim 32 , wherein the pharmaceutical composition comprises from about 70-80 weight % of the rimegepant or a pharmaceutically acceptable salt thereof, about 10-20 weight % fish gelatin, about 10-20 weight % of a filler, and 0.1-5.0 weight % of a flavorant.
38 . The method of claim 32 , wherein the pharmaceutical composition is capable of disintegrating or dispersing within an interval selected from 1 to 60 seconds, 1 to 30 seconds, 1 to 10 seconds, and 2 to 8 seconds, after being placed in contact with a fluid.
39 . The method of claim 38 , wherein the fluid comprises saliva.
40 . The method of claim 32 , wherein the pharmaceutical composition is in the form of a tablet.
41 . The method of claim 32 , wherein the pharmaceutical composition provides an AUC 0-t of from about 80-125% of 5000 (hr*ng/mL).