IP Library Patent Application 16767134
Patent Application
App. No. 16/767,134

RIMEGEPANT FOR CGRP RELATED DISORDERS

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Quick Facts
Patent No.
US None
App. No.
16/767,134
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.

Claims (21)

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.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2023
From: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD
To: PFIZER IRELAND PHARMACEUTICALS
Reel/Frame 063269/0373 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 7, 2022
From: BIOHAVEN PHARMACEUTICAL IRELAND DESIGNATED ACTIVITY COMPANY
To: PFIZER IRELAND PHARMACEUTICALS
Reel/Frame 061885/0685 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2020
From: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
To: BIOHAVEN PHARMACEUTICAL IRELAND DAC
Reel/Frame 053404/0483 →