Use of norepinephrine reuptake modulators for preventing and treating vasomotor symptoms

• US 20040143008A1
• Filed: 10/14/2003
• Published: 07/22/2004
• Est. Priority Date: 10/15/2002
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Deecher, Darlene Coleman, Sipe, Kimberly Jean, Merchenthaler, Istvan Jozsef, Leventhal, Liza, OʼConnor, Lawrence Thomas
• Granted Patent: US 7,345,096 B2
• Time in Patent Office: Days
• US Class Current: 514/521
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/4174 Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/497 containing further heterocyclic rings
• CPC Class Codes: A61K 31/5377 not condensed and containing further heterocyclic rings, e.g. timolol
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The present invention relates to the use of compounds and composition of compounds that modulate norepinephrine levels for the prevention and treatment of vasomotor symptoms, such as hot flush, caused by, inter alia, thermoregulatory dysfunctions.

Claims

1. A method for treating or preventing vasomotor symptoms in a subject in need thereof, comprising the step of:

administering to said subject a therapeutically effective amount of at least one dual NRI/SRI compound or pharmaceutically acceptable salt thereof,

wherein said amount is less than about 37.5 mg/day.

2. A method according to claim 1,

wherein said amount is less than about 30 mg/day.

3. A method according to claim 1,

wherein said amount is less than about 25 mg/day.

4. A method according to claim 1,

wherein said amount is less than about 20 mg/day.

5. A method according to claim 1,

wherein said amount is less than about 15 mg/day.

6. A method according to claim 1,

wherein said amount is less than about 10 mg/day.

7. A method according to claim 1,

wherein said amount is less than about 5 mg/day.

8. A method according to claim 1,

wherein said dual NRI/SRI compound is a compound selected from the group consisting of venlafaxine, O-desmethyl-venlafaxine, milnacipran, duloxetine, and combinations and pharmaceutically acceptable salts thereof.

9. A method according to claim 1,

wherein said dual NRI/SRI compound is venlafaxine or a pharmaceutically acceptable salt thereof.

10. A method according to claim 1,

wherein said dual NRI/SRI compound is O-desmethyl-venlafaxine or a pharmaceutically acceptable salt thereof.

11. A method according to claim 1,

wherein said dual NRI/SRI compound is milnacipran or a pharmaceutically acceptable salt thereof.

12. A method according to claim 1,

wherein said dual NRI/SRI compound is duloxetine or a pharmaceutically acceptable salt thereof.

13. A method according to claim 1,

wherein said vasomotor symptom is hot flush.

14. A method according to claim 1,

wherein said vasomotor symptom is caused by a thermoregulatory dysfunction.

15. A method according to claim 1,

wherein said subject is human.

16. A method according to claim 15,

wherein said human is a female.

17. A method according to claim 16,

wherein said female is pre-menopausal.

18. A method according to claim 16,

wherein said female is peri-menopausal.

19. A method according to claim 16,

wherein said female is post-menopausal.

20. A method according to claim 15,

wherein said human is a male.

21. A method according to claim 20,

wherein said male is naturally, chemically or surgically andropausal.