# US 10,441,641 B2 · Botulinum toxin and the treatment of primary disorders of mood and affect

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- Number: US 10,441,641 B2
- Document ID: US10441641B2
- Status: Granted
- Kind: B2
- Application number: 14/852,990
- Filed: 2015-09-14
- Published: 2016-02-18
- Granted: 2019-10-15
- Earliest claimed: 2005-06-14
- Assignees: Revance Therapeutics, Inc.
- Applicants: Revance Therapeutics, Inc.
- Inventors: Gary E. Borodic
- Web page: https://patentgrep.com/patent/US10441641B2

## CPC

- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- 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 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61K 49/0004: {Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions}
- C12Y 304/24069: Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
- A61K 2121/00: Preparations for use in therapy
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- C12Y: ENZYMES
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method of treating circadian rhythm disorders includes identifying a subject with a circadian rhythm disorder or at least one symptom of a circadian rhythm disorder and administering an effective amount of a composition comprising a botulinum toxin and a pharmaceutically acceptable carrier to said subject thereby reducing at least one symptom of a circadian rhythm disorder.

## Claims

### Claim 1

A method for simultaneously treating both sleep disorder and depression comprising:
(i) identifying a subject with both sleep disorder and depression; and
(ii) administering an effective amount of a composition comprising a botulinum toxin immunotype A and a pharmaceutically acceptable carrier to the subject, thereby reducing at least one symptom of both sleep disorder and depression;
wherein said sleep disorder is sleep onset insomnia or sleep maintenance insomnia.

### Claim 2 (depends on 1)

The method of claim 1, wherein the botulinum toxin is botulinum toxin type A from Hall strain Clostridium botulinum.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition is administered by an injection.

### Claim 4 (depends on 3)

The method of claim 3, wherein the step of administering the composition to the subject further comprises at least two injections sites, wherein the injections are multifocal.

### Claim 5 (depends on 3)

The method of claim 3, wherein the composition is administered to at least one of a forehead, scalp, neck, or periocular region of the subject.

### Claim 6 (depends on 3)

The method of claim 3, wherein the injection is transcutaneous, subcutaneous, transdermal, or intramuscular.

### Claim 7 (depends on 1)

The method of claim 1, wherein the effective amount of the composition is a dose between 5-3000 units.

### Claim 8 (depends on 1)

The method of claim 1, wherein the composition decreases choline acetyltransferase activity.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition decreases synthesis of acetylcholine.