ORAL FAST-DISPERSING DOSAGE FORM OF RIMEGEPANT
Provided is a fast-dispersing dosage form for oral delivery, wherein the fast-dispersing dosage form includes a rimegepant. Also provided is a method for delivering rimegepant to a subject, wherein the method includes orally administering to the subject a fast-dispersing dosage form including rimegepant.
1 . A method of treating migraine in a patient in need thereof, comprising orally administering to the patient a fast-dispersing pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of rimegepant, or a pharmaceutically acceptable salt thereof.
2 . The method according to claim 1 , wherein administering the pharmaceutical composition results in migraine pain freedom within 2 hours of the time of administration.
3 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 21.2% of patients achieving migraine pain freedom within 2 hours of the time of administration.
4 . The method according to claim 1 , wherein administering the pharmaceutical composition results in freedom from most bothersome symptoms within 2 hours of the time of administration.
5 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 35.1% of patients achieving freedom from most bothersome symptoms within 2 hours of the time of administration.
6 . The method according to claim 5 , wherein the most bothersome symptoms comprise photophobia, nausea, phonophobia, or a combination thereof.
7 . The method according to claim 1 , wherein administering the pharmaceutical composition results in pain relief within 90 minutes of the time of administration.
8 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 49.6% of patients achieving pain relief within 90 minutes of the time of administration.
9 . The method according to claim 1 , wherein administering the pharmaceutical composition results in achieving pain relief within 2 hours of the time of administration.
10 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 59.3% of patients achieving pain relief within 2 hours of the time of administration.
11 . The method according to claim 1 , wherein administering the pharmaceutical composition results in sustained pain relief within 2 to 48 hours of the time of administration.
12 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 42.2% of patients achieving sustained pain relief within 2 to 48 hours of the time of administration.
13 . The method according to claim 1 , wherein administering the pharmaceutical composition results in sustained pain freedom within 2 to 48 hours of the time of administration.
14 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 13.5% of patients achieving sustained pain freedom within 2 to 48 hours of the time of administration.
15 . The method according to claim 1 , wherein administering the pharmaceutical composition results in reduced usage of rescue medication within 24 hours of the time of administration.
16 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 14.2% of patients using rescue medication within 24 hours of the time of administration.
17 . The method according to claim 1 , wherein administering the pharmaceutical composition results in normal function within 2 hours of the time of administration.
18 . The method according to claim 1 , wherein administering the pharmaceutical composition results in about 38.1% of patients reporting normal function within 2 hours of the time of administration.
19 . The method according to claim 1 , wherein the daily dose of rimegepant is about 75 mg.
20 . The method according to claim 1 , wherein the pharmaceutical composition is administered to a patient up to 15 times in a 30-day period.
21 . The method according to claim 1 , wherein the pharmaceutically acceptable salt or rimegepant is rimegepant hemi sulfate.
22 . The method according to claim 1 , wherein the daily dose of rimegepant hemisulfate is about 85.65 mg.
23 . The method according to claim 1 , wherein the pharmaceutical composition further includes benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, vanillin, or a combination thereof.
24 . The method according to claim 1 , wherein about 1.3% or less of patients who received the pharmaceutical composition experience nausea.
25 . The method according to claim 1 , wherein about 0.15% or less of patients who received the pharmaceutical composition experience hypersensitivity.
26 . The method according to claim 25 , wherein the hypersensitivity comprises dyspnea, rash, or a combination thereof.