# US 9,517,254 B2 · Treatment regimens

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- Number: US 9,517,254 B2
- Document ID: US9517254B2
- Status: Granted
- Kind: B2
- Application number: 14/420,112
- Filed: 2013-08-06
- Published: 2015-06-04
- Granted: 2016-12-13
- Earliest claimed: 2012-08-06
- Assignees: S1 Biopharma, Inc.
- Applicants: S1 Biopharma, Inc.
- Inventors: Nicolas G. Sitchon; Robert E. Pyke; John F. Kaufmann
- Web page: https://patentgrep.com/patent/US9517254B2

## CPC

- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 38/095: Oxytocins; Vasopressins; Related peptides
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- A61P 15/10: for impotence
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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

The invention further relates to compounds, pharmaceutical compositions and methods for treating all disorders of human sexual function including hypoactive sexual desire disorder (HSDD) in a subject.

## Claims

### Claim 1

A composition comprising a 5-HT2A antagonist, a norepinephrine-dopamine reuptake inhibitor, an oxytocin receptor (OXTR) agonist, and a pharmaceutically acceptable carrier.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the 5-HT2A antagonist is also a 5-HT1A receptor agonist.

### Claim 3 (depends on 1)

The composition of claim 1, comprising trazodone, bupropion, and oxytocin.

### Claim 4 (depends on 1)

The composition of claim 1, comprising bupropion in a dosage range of 200-450 mg.

### Claim 5 (depends on 1)

The composition of claim 1, comprising trazodone in a dosage range of 25-450 mg.

### Claim 6 (depends on 1)

The composition of claim 1, comprising oxytocin in a dosage range of 4-400 International Units.

### Claim 7 (depends on 1)

The composition of claim 1, comprising trazodone in a dosage range of 1-450 mg, bupropion in a dosage range of 1-450 mg, and oxytocin in a dosage range of 4-400 International Units.

### Claim 8

A method of making a composition comprising combining a 5-HT1A agonist, a 5-HT2A antagonist, a norepinephrine-dopamine reuptake inhibitor, an oxytocin receptor (OXTR) agonist, and a pharmaceutically acceptable carrier.

### Claim 9 (depends on 8)

The method of claim 8, comprising combining bupropion, trazodone, oxytocin, and a pharmaceutically acceptable carrier.

### Claim 10 (depends on 1)

A method of treating a sexual disorder in a subject comprising administering to the subject a composition according to claim 1.

### Claim 11 (depends on 10)

The method of claim 10, wherein the sexual disorder is hypoactive sexual desire disorder (HSDD).

### Claim 12 (depends on 10)

The method of claim 10, wherein the sexual disorder is female orgasm disorder (FOD).

### Claim 13 (depends on 10)

The method of claim 10, wherein the sexual disorder is female sexual arousal disorder (FSAD).

### Claim 14 (depends on 10)

The method of claim 10, wherein the sexual disorder is sexual pain dysfunction.

### Claim 15 (depends on 10)

The method of claim 10, wherein the sexual disorder is male HSDD.

### Claim 16 (depends on 1)

A method of treating a cognitive disorder in a subject comprising administering to the subject a composition according to claim 1.

### Claim 17 (depends on 16)

The method in claim 16, wherein the cognitive disorder is dementia.

### Claim 18 (depends on 17)

The method in claim 17, wherein the dementia is Alzheimer's disease, frontotemporal lobar degeneration, dementia with Lewy bodies, Parkinson's disease, Huntington's disease, multi-infarct dementia, dementia resulting from infections affecting the central nervous system, dementia resulting from chronic drug use, dementia resulting from hydrocephalus, dementia resulting from brain injury, or dementia resulting from a brain tumor.

### Claim 19 (depends on 16)

The method in claim 16, wherein the cognitive disorder is cognitive disability.

### Claim 20 (depends on 19)

The method in claim 19, wherein the cognitive disability is schizophrenia, schizoaffective disorder, bipolar disorder, or major depression.