# US 11,896,582 B2 · Use and composition for treating myasthenia gravis and other myasthenic syndromes

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- Number: US 11,896,582 B2
- Document ID: US11896582B2
- Status: Granted
- Kind: B2
- Application number: 17/085,964
- Filed: 2020-10-30
- Published: 2021-02-18
- Granted: 2024-02-13
- Earliest claimed: 2017-01-09
- Assignees: DAS-MG, Inc.
- Applicants: Das-Mg, Inc.
- Inventors: Kathleen E. Clarence-Smith
- Web page: https://patentgrep.com/patent/US11896582B2

## CPC

- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 31/4425: Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 21/04: for myasthenia gravis
- 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

The present invention provides a new compositions and methods to enable the safe administration of pyridostigmine to mammalian subjects, including those with myasthenic syndromes including Myasthenia Gravis, with said compositions comprising combinations, including fixed-dose combinations, of an antagonist of the 5-hydroxytryptamine subtype-3 receptor (“5HT3-antagonist”) with an effective dose of pyridostigmine. The compositions and methods of the present invention provide for an increase in the tolerable dose of pyridostigmine over that of pyridostigmine when administered alone.

## Claims

### Claim 1

A fixed-dose combination product for administration to a mammal comprising a pharmaceutical composition in dosage unit form comprising as active ingredients (a) between 2 mg and 16 mg of a 5HT3-antagonist and (b) between 15 mg and 800 mg of pyridostigmine, which are (c) in admixture with a pharmaceutically acceptable carrier or vehicle.

### Claim 2 (depends on 1)

The fixed-dose combination product of claim 1, wherein the pyridostigmine is pyridostigmine bromide.

### Claim 3 (depends on 2)

The fixed-dose combination product of claim 2, wherein the 5HT3-antagonist is an ondansetron 5HT3-antagonist comprising ondansetron or a pharmaceutically acceptable salt or solvate thereof.

### Claim 4 (depends on 3)

The fixed-dose combination product of claim 3, wherein the product is an immediate release formulation.

### Claim 5 (depends on 3)

The fixed-dose combination product of claim 3, wherein the product is an extended release formulation.