# US 11,998,552 B2 · Pharmaceutical compositions comprising meloxicam

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- Number: US 11,998,552 B2
- Document ID: US11998552B2
- Status: Granted
- Kind: B2
- Application number: 18/337,552
- Filed: 2023-06-20
- Published: 2023-10-26
- Granted: 2024-06-04
- Earliest claimed: 2020-12-31
- Assignees: Axsome Therapeutics, Inc.
- Applicants: Axsome Therapeutics, Inc.
- Inventors: Herriot Tabuteau
- Web page: https://patentgrep.com/patent/US11998552B2

## CPC

- A61K 31/5415: ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/2009: {Inorganic compounds}
- 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 47/08: containing oxygen, {e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides}
- A61K 47/40: Cyclodextrins; Derivatives thereof
- A61P 25/06: Antimigraine agents
- 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

## 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 dosage form to a migraine patient, at least twice a month for at least six months, during a migraine attack, wherein the dosage form comprises a combination of a meloxicam and a rizatriptan, wherein the human migraine patient experiences relief of migraine pain as a result of orally administering the dosage form to the migraine patient, and wherein the dosage form is well tolerated with long-term dosing in the migraine patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the migraine patient has nausea, photophobia, or phonophobia associated with migraine.

### Claim 3 (depends on 2)

The method of claim 2, wherein the migraine patient experiences a reduction in nausea as a result of orally administering the dosage form to the migraine patient.

### Claim 4 (depends on 2)

The method of claim 2, wherein the migraine patient experiences a reduction in photophobia as a result of orally administering the dosage form to the migraine patient.

### Claim 5 (depends on 2)

The method of claim 2, wherein the migraine patient experiences a reduction in phonophobia as a result of orally administering the dosage form to the migraine patient.

### Claim 6 (depends on 1)

The method of claim 1, wherein the dosage form further contains about 400 mg to about 600 mg of a bicarbonate.

### Claim 7 (depends on 1)

The method of claim 1, wherein the dosage form contains about 5 mg to about 50 mg of the meloxicam.

### Claim 8 (depends on 6)

The method of claim 6, wherein the dosage form further contains about 50 mg to about 200 mg of a SBEβCD.

### Claim 9 (depends on 8)

The method of claim 8, wherein the dosage form is a solid oral dosage form having a shorter Tmax of meloxicam in a human being than a reference dosage form that: 1) contains the same amount of the meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate.

### Claim 10 (depends on 1)

The method of claim 1, wherein about 1 mg to about 50 mg of the rizatriptan is present in the dosage form based upon the weight of rizatriptan in the free base form.

### Claim 11 (depends on 10)

The method of claim 10, wherein the rizatriptan is present in a salt form in an amount that is a molar equivalent of about 10 mg of rizatriptan in the free base form.

### Claim 12 (depends on 11)

The method of claim 11, wherein the rizatriptan is present as rizatriptan benzoate.

### Claim 13 (depends on 1)

The method of claim 1, wherein the dosage form contains about 10 mg to about 30 mg of the meloxicam.

### Claim 14 (depends on 13)

The method of claim 13, wherein the dosage form contains about 20 mg of the meloxicam.

### Claim 15 (depends on 8)

The method of claim 8, wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin.

### Claim 16 (depends on 8)

The method of claim 8, wherein the dosage form contains about 50 mg to about 150 mg of the SBEβCD.

### Claim 17 (depends on 6)

The method of claim 6, wherein the bicarbonate is sodium bicarbonate.

### Claim 18 (depends on 1)

The method of claim 1, wherein the human migraine patient is able to return to normal activities within 24 hours after receiving the treatment.