# US 8,785,396 B2 · Method and composition for treating migraines

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- Number: US 8,785,396 B2
- Document ID: US8785396B2
- Status: Granted
- Kind: B2
- Application number: 13/293,017
- Filed: 2011-11-09
- Published: 2012-03-22
- Granted: 2014-07-22
- Earliest claimed: 2007-10-24
- Assignees: MannKind Corporation
- Applicants: Andrea Leone-Bay; Grayson W. Stowell; Joseph J. Guarneri; Dawn M. Carlson; Marshall Grant; Chad C. Smutney
- Inventors: Andrea Leone-Bay; Grayson W. Stowell; Joseph J. Guarneri; Dawn M. Carlson; Marshall Grant; Chad C. Smutney
- Web page: https://patentgrep.com/patent/US8785396B2

## CPC

- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 9/1617: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1688: {resulting in pure drug agglomerate optionally containing up to 5% of excipient}
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 31/4196: 1,2,4-Triazoles
- A61K 31/422: not condensed and containing further heterocyclic rings
- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- A61K 31/495: having six-membered rings with two {or more} nitrogen atoms as the only ring heteroatoms, e.g. piperazine {or tetrazines}(A61K31/48 takes precedence {; with three nitrogen atoms A61K31/53})
- A61K 38/26: Glucagons
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 25/02: for peripheral neuropathies
- A61P 25/06: Antimigraine agents
- A61M 2202/064: Powder
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method for treating migraines is disclosed. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent, including small molecules and peptides being administered to a patient in need of treatment. In particular, the drug delivery system is designed for inhalation for delivery of drugs to the pulmonary circulation in a rapid and therapeutically effective manner.

## Claims

### Claim 1

A pharmaceutical composition comprising bis-3,6-[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine or a salt thereof, 1-50 mg of sumatriptan or rizatriptan, and an aliphatic amino acid selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine, and serine, wherein said aliphatic amino acid is about 0.5% to about 30% by weight of the composition.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, comprising bis -3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine and sumatriptan in a dry powder form.

### Claim 3 (depends on 2)

The pharmaceutical composition of claim 2, wherein the composition is inhalable.

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein the composition further comprises an excipient.

### Claim 5 (depends on 2)

The pharmaceutical composition of claim 2, wherein the dry powder comprises microparticles, wherein from about 35% to about 75% of said microparticles have an aerodynamic diameter of less than 5.8 μm.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition further comprises L-leucine.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is alanine.

### Claim 8 (depends on 1)

The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is glycine.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is isoleucine.

### Claim 10 (depends on 1)

The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is norleucine.

### Claim 11 (depends on 1)

The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is serine.

### Claim 12 (depends on 1)

The pharmaceutical composition of claim 1, comprising bis -3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine and rizatriptan in a dry powder form.

### Claim 13 (depends on 1)

A method of treating a migraine comprising: providing a patient with migraine symptoms an inhaler comprising the pharmaceutical composition of claim 1 in a dry powder form comprising bis-3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine, the aliphatic amino acid and 1-50 mg of sumatriptan or rizatriptan; wherein the aliphatic amino acid is L-leucine and wherein a therapeutically effective amount of said dry powder composition is administered to said patient by oral inhalation.