Pharmaceutical compositions comprising meloxicam

Abstract

Disclosed herein is a method of treating migraine in patients with a history of inadequate response to prior migraine treatments comprising: selecting a patient who, for at least the past month: 1) has had 2 to 8 migraines per month, and 2a) according to the patient, is never or rarely comfortable enough with the patient's migraine medication to be able to plan daily activities, 2b) according to the patient, after taking migraine medication, the patient never or rarely feels in control of the patient's migraines enough so that the patient feels there will be no disruption in the patient's daily activities, 2c) has an mTOQ-4 score of 0, and/or 2d) has a history of depression; and administering a combination of 20 mg of meloxicam and 10 mg of rizatriptan to the patient during a migraine attack.

1 . A method of treating migraine in patients with a history of inadequate response to prior migraine treatments comprising, selecting a patient who, for at least the past four weeks: 1) has had 2 to 8 migraines per month, and 2) according to the patient, is never or rarely comfortable enough with the patient's migraine medication to be able to plan daily activities; and after the patient is selected, administering a combination of 20 mg of meloxicam or a pharmaceutically acceptable salt thereof and 10 mg of rizatriptan or a pharmaceutically acceptable salt thereof to the patient during a migraine attack. 
     
     
         2 . The method of  claim 1 , wherein the meloxicam and the rizatriptan are present in a single dosage form. 
     
     
         3 . The method of  claim 2 , wherein the dosage form further comprises a bicarbonate. 
     
     
         4 . The method of  claim 2 , wherein the dosage form further comprises a cyclodextrin. 
     
     
         5 . The method of  claim 1 , wherein the meloxicam and the rizatriptan are orally administered to the patient. 
     
     
         6 . The method of  claim 1 , wherein the combination is administered while the patient has mild migraine pain. 
     
     
         7 . The method of  claim 1 , wherein the combination is administered while the patient has moderate migraine pain. 
     
     
         8 . The method of  claim 1 , wherein the combination is administered while the patient has severe migraine pain. 
     
     
         9 . The method of  claim 3 , wherein the dosage form further comprises a cyclodextrin. 
     
     
         10 . The method of  claim 4 , wherein the cyclodextrin is sulfobutyl ether-β-cyclodextrin (SBEβCD). 
     
     
         11 . The method of  claim 9 , wherein the cyclodextrin is sulfobutyl ether-β-cyclodextrin (SBEβCD). 
     
     
         12 . The method of  claim 10 , wherein the meloxicam is in an inclusion complex with SBEβCD. 
     
     
         13 . The method of  claim 11 , wherein the meloxicam is in an inclusion complex with SBEβCD. 
     
     
         14 . The method of  claim 1 , wherein the meloxicam is in the free acid form. 
     
     
         15 . The method of  claim 1 , wherein the rizatriptan is in a salt form. 
     
     
         16 . The method of  claim 15 , wherein the rizatriptan is present as rizatriptan benzoate. 
     
     
         17 . The method of  claim 3 , wherein the bicarbonate is sodium bicarbonate or potassium bicarbonate. 
     
     
         18 . The method of  claim 9 , wherein the bicarbonate is sodium bicarbonate or potassium bicarbonate. 
     
     
         19 . The method of  claim 17 , wherein about 500 mg of sodium bicarbonate is present in the combination. 
     
     
         20 . The method of  claim 18 , wherein about 500 mg of sodium bicarbonate is present in the combination. 
     
     
         21 . The method of  claim 10 , wherein about 133.6 mg of SBEβCD is present in the combination. 
     
     
         22 . The method of  claim 11 , wherein about 133.6 mg of SBEβCD is present in the combination.