Rimegepant for cgrp related disorders

Abstract

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.

What is claimed is: 
     
         1 . 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, in order to provide decrease in the number of migraines per month for said patient of at least 20%. 
     
     
         2 . The method of  claim 1  wherein the decrease in the number of migraines per month for said patient of at least 30%. 
     
     
         3 . The method of  claim 2  wherein the decrease in the number of migraines per month for said patient of at least 40%. 
     
     
         4 . 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, in order to provide Pain Freedom of the pharmaceutical composition of at about 30% greater than placebo. 
     
     
         5 . The method of  claim 1  wherein the Pain Freedom of the pharmaceutical composition is at least about 50% greater than placebo. 
     
     
         6 . The method of  claim 4  wherein the Pain Freedom of the pharmaceutical composition is from about 30-75% greater than placebo. 
     
     
         7 . The method of  claim 6  wherein the Pain Freedom of the pharmaceutical composition is from about 35-65% greater than placebo. 
     
     
         8 . 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, in order to provide Freedom from MBS of the pharmaceutical composition of at about 30% greater than placebo. 
     
     
         9 . The method of  claim 8  wherein the Freedom from MBS of the pharmaceutical composition is at least about 40% greater than placebo. 
     
     
         10 . The method of  claim 8  wherein the Freedom from MBS of the pharmaceutical composition is from about 30-50% greater than placebo. 
     
     
         11 . The method of  claim 4  which provides an AUCo —t  of from about 80-125% of 5000 (hr*ng/mL). 
     
     
         12 . The method of  claim 4  which provides a C max  of from about 80-125% of 835 (ng/mL). 
     
     
         13 . A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of rimegepant, or a pharmaceutically acceptable salt thereof, in order to provide an AUC 0-t  of from about 80-125% of 5000 (hr*ng/mL). 
     
     
         14 . The pharmaceutical composition of  claim 13  which comprises about 75 mg of rimegepant or a pharmaceutically acceptable salt thereof. 
     
     
         15 . The pharmaceutical composition of  claim 13  wherein the rimegepant is in the form of a hemisulfate sesquihydrate salt. 
     
     
         16 . The pharmaceutical composition of  claim 13  in the form of a tablet. 
     
     
         17 . The pharmaceutical composition of  claim 16  comprising from about 50-60 wt % rimegepant hemisulfate sesquihydrate, about 30-35 wt % microcrystalline cellulose, about 2-7 wt % hydroxypropyl cellulose, about 3-7 wt % croscarmellose sodium, and about 0.1-1.0 wt % magnesium stearate. 
     
     
         18 . The pharmaceutical composition of  claim 17  comprising about 57.1 wt % rimegepant hemisulfate sesquihydrate, about 33.4 wt % microcrystalline cellulose, about 4.0 wt % hydroxypropyl cellulose, about 5.0 wt % croscarmellose sodium, and about 0.5 wt % magnesium stearate. 
     
     
         19 . The pharmaceutical composition of  claim 13  in the form of an oral solid molded fast-dispersing dosage form. 
     
     
         20 . The pharmaceutical composition of  claim 19  comprising from about 70-80 wt % rimegepant hemisulfate sesquihydrate, about 10-20 wt % fish gelatin, about 10-20 wt % of a filler, and 0.1-5.0 wt % of a flavorant. 
     
     
         21 . The pharmaceutical composition of  claim 20  wherein the filler is mannitol.