# US 12,005,118 B2 · Pharmaceutical compositions comprising meloxicam > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,118 B2 - Document ID: US12005118B2 - Status: Granted - Kind: B2 - Application number: 18/159,232 - Filed: 2023-01-25 - Published: 2023-06-08 - Granted: 2024-06-11 - Earliest claimed: 2022-05-19 - Assignees: Axsome Therapeutics, Inc. - Applicants: Axsome Therapeutics, Inc. - Inventors: Herriot Tabuteau - Web page: https://patentgrep.com/patent/US12005118B2 ## CPC - A61K 47/02: Inorganic compounds - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 9/2009: {Inorganic compounds} - A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin} - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61K 31/4196: 1,2,4-Triazoles - A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) - A61K 31/5415: ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam - A61K 31/724: Cyclodextrins - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/40: Cyclodextrins; Derivatives thereof - A61K 47/61: the organic macromolecular compound being a polysaccharide or a derivative thereof - A61K 47/6951: {using cyclodextrin (cyclodextrins used as simple excipients A61K47/40)} - A61P 25/00: Drugs for disorders of the nervous system - A61P 25/06: Antimigraine agents - C08B 37/0012: {Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof} - C08B 37/0015: {Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes} - C08L 5/16: Cyclodextrin; Derivatives thereof - A61K 9/0007: {Effervescent (A61K9/0065 takes precedence)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C08B: POLYSACCHARIDES; DERIVATIVES THEREOF (polysaccharides containing less than six saccharide radicals attached to each other by glycosidic linkages C07H; fermentation or enzyme-using processes C12P19/00; sugar industry C13; production of cellulose D21) - C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06) ## Abstract Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less. ## Claims ### Claim 1 A method of treating migraine, comprising orally administering a combination of about 15 mg to about 30 mg of a meloxicam, and a rizatriptan, to a human being in need thereof, wherein the human being has a history of depression and is suffering from migraine pain or aura. ### Claim 2 (depends on 1) The method of claim 1, wherein the rizatriptan is orally administered to the human being at a dose of about 8 mg to about 13 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan. ### Claim 3 (depends on 2) The method of claim 2, wherein the human being experiences a reduction in migraine pain at one hour after the combination is orally administered. ### Claim 4 (depends on 2) The method of claim 2, wherein the human being experiences a reduction in migraine pain at 24 hours after the combination is orally administered. ### Claim 5 (depends on 2) The method of claim 2, wherein the human being is suffering from moderate to severe migraine pain. ### Claim 6 (depends on 2) The method of claim 2, wherein the combination contains about 20 mg of the meloxicam free acid, or the molar equivalent amount of a salt form of meloxicam. ### Claim 7 (depends on 2) The method of claim 2, wherein the human being is suffering from photophobia. ### Claim 8 (depends on 7) The method of claim 7, wherein the human being experiences a reduction in photophobia at two hours after the combination is orally administered. ### Claim 9 (depends on 8) The method of claim 8, wherein the combination contains about 20 mg of the meloxicam free acid, or the molar equivalent amount of a salt form of meloxicam. ### Claim 10 (depends on 2) The method of claim 2, wherein the human being is suffering from phonophobia. ### Claim 11 (depends on 10) The method of claim 10, wherein the human being experiences a reduction in phonophobia at two hours after the combination is orally administered. ### Claim 12 (depends on 11) The method of claim 11, wherein the combination contains about 20 mg of the meloxicam free acid, or the molar equivalent amount of a salt form of meloxicam. ### Claim 13 (depends on 2) The method of claim 2, wherein the human being is suffering from nausea. ### Claim 14 (depends on 13) The method of claim 13, wherein the human being experiences a reduction in nausea at two hours after the combination is orally administered. ### Claim 15 (depends on 14) The method of claim 14, wherein the combination contains about 20 mg of the meloxicam free acid, or the molar equivalent amount of a salt form of meloxicam. ### Claim 16 (depends on 2) The method of claim 2, wherein the migraine is associated with an aura. ### Claim 17 (depends on 2) The method of claim 2, wherein the human being has a reduced use of pain medication other than meloxicam, as compared to the use of the pain medication that would have occurred without receiving the meloxicam. ### Claim 18 (depends on 2) The method of claim 2, wherein the human being has a reduced use of pain medication other than meloxicam, wherein the use of the pain medication is reduced by at least about 20% as compared to the use of the pain medication that would have occurred without receiving the meloxicam. ### Claim 19 (depends on 2) The method of claim 2, wherein the human being has a Tmax of meloxicam that is two hours or less after the combination is administered. ### Claim 20 (depends on 2) The method of claim 2, wherein the human being has a Tmax of meloxicam that is one hour or less after the combination is administered. ### Claim 21 (depends on 6) The method of claim 6, wherein the migraine is associated with an aura. ### Claim 22 (depends on 6) The method of claim 6, wherein the human being has a reduced use of pain medication other than meloxicam, as compared to the use of the pain medication that would have occurred without receiving the meloxicam. ### Claim 23 (depends on 6) The method of claim 6, wherein the human being has a reduced use of pain medication other than meloxicam, wherein the use of the pain medication is reduced by at least about 20% as compared to the use of the pain medication that would have occurred without receiving the meloxicam. ### Claim 24 (depends on 6) The method of claim 6, wherein the human being has a Tmax of meloxicam that is two hours or less after the combination is administered. ### Claim 25 (depends on 6) The method of claim 6, wherein the human being has a Tmax of meloxicam that is one hour or less after the combination is administered. ### Claim 26 (depends on 1) The method of claim 1, wherein the rizatriptan is rizatriptan benzoate. ### Claim 27 (depends on 1) The method of claim 1, wherein the meloxicam is in the free acid form or a salt form. ### Claim 28 (depends on 2) The method of claim 2, wherein the combination contains about 20 mg of the meloxicam free acid, or the molar equivalent amount of a salt form of meloxicam, and 10 mg of the rizatriptan free base, or the molar equivalent amount of a salt form of rizatriptan.