# US 12,594,273 B2 · Intranasal DHE for the treatment of headache

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- Number: US 12,594,273 B2
- Document ID: US12594273B2
- Status: Granted
- Kind: B2
- Application number: 17/834,583
- Filed: 2022-06-07
- Published: 2023-01-05
- Granted: 2026-04-07
- Earliest claimed: 2013-09-24
- Assignees: Satsuma Pharmaceuticals, Inc.
- Applicants: Satsuma Pharmaceuticals, Inc.
- Inventors: Shunji Haruta; Nikhilesh N. Singh; John Kollins; Salvador Rico
- Web page: https://patentgrep.com/patent/US12594273B2

## CPC

- A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
- A61K 9/0043: {Nose}
- A61K 9/146: {with organic macromolecular compounds}
- A61K 31/48: Ergoline derivatives, e.g. lysergic acid, ergotamine
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 25/06: Antimigraine agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

Presented herein are powder formulations comprising dihydroergotamine (DHE), or a pharmaceutically acceptable salt thereof. In addition to such formulations, also presented herein are methods comprising intranasally administering powder formulations comprising dihydroergotamine, or a pharmaceutically acceptable salt thereof. The presented methods can be used for treating headache, for example, for rapid onset treatment of headache, including migraine, e.g. acute treatment of migraine with or without aura.

## Claims

### Claim 1

A nasal delivery device, comprising
a pharmaceutical nasal dosage form comprising dihydroergotamine mesylate and microcrystalline cellulose;
wherein dihydroergotamine mesylate is present in the pharmaceutical nasal dosage form in an amount of 6 mg to about 8 mg,
wherein said microcrystalline cellulose is present in the pharmaceutical nasal dosage form in an amount from about 40% to about 60% w/w; and
wherein said pharmaceutical nasal delivery device provides a Tmax of dihydroergotamine mesylate of less than or equal to about 30 minutes; and
the nasal delivery device requires no priming.

### Claim 2 (depends on 1)

The nasal delivery device of claim 1, wherein said dihydroergotamine mesylate is present in about 18% w/w of said pharmaceutical nasal dosage form.

### Claim 3 (depends on 1)

The nasal delivery device of claim 1, wherein said dihydroergotamine mesylate is present in about 23% w/w of said pharmaceutical nasal dosage form.

### Claim 4 (depends on 1)

The nasal delivery device of claim 1, wherein said dihydroergotamine mesylate is present in an amount of 6 mg.

### Claim 5 (depends on 1)

The nasal delivery device of claim 1, wherein the pharmaceutical nasal dosage form is a powder pharmaceutical nasal dosage form.

### Claim 6 (depends on 1)

The nasal delivery device of claim 1, wherein the pharmaceutical nasal dosage form is in a unit dose form.

### Claim 7 (depends on 1)

The nasal delivery device of claim 1, wherein the microcrystalline cellulose is present in an amount of about 50% to about 60% of the total weight of said pharmaceutical nasal dosage form.

### Claim 8 (depends on 7)

The nasal delivery device of claim 7, wherein the microcrystalline cellulose is present in an amount of about 60% of a total weight of said pharmaceutical nasal dosage form.

### Claim 9 (depends on 1)

The nasal delivery device of claim 1, wherein said microcrystalline cellulose has a mean particle size diameter of about 100 μm or less.

### Claim 10 (depends on 9)

The nasal delivery device of claim 9, wherein said microcrystalline cellulose has a mean particle size diameter of about 50 μm or less.

### Claim 11 (depends on 10)

The nasal delivery device of claim 10, wherein said microcrystalline cellulose has a mean particle size diameter of about 30 μm or less.

### Claim 12 (depends on 5)

The nasal delivery device of claim 5, wherein the total weight of the powder pharmaceutical nasal dosage form is about 35 mg.

### Claim 13 (depends on 12)

The nasal delivery device of claim 12 wherein the total weight of the powder pharmaceutical nasal dosage form is about 30 mg.

### Claim 14 (depends on 1)

A method of delivering the nasal pharmaceutical dosage form, comprising:
administering to a nostril of a subject the pharmaceutical nasal dosage form by the nasal delivery device of claim 1.

### Claim 15 (depends on 1)

A method of treating a headache, comprising:
administering to a nostril of a subject the pharmaceutical nasal dosage form by the nasal delivery device of claim 1.

### Claim 16 (depends on 14)

The method of claim 14, wherein the pharmaceutical nasal dosage form is administered at a first time and a second time.