Use of Flibanserin in the Treatment of Obesity

• US 20080242678A1
• Filed: 07/31/2006
• Published: 10/02/2008
• Est. Priority Date: 08/03/2005
• Status: Active Grant

• Current Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Original Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Inventors: Ceci, Angelo, Schindler, Marcus
• Granted Patent: US 8,227,476 B2
• Time in Patent Office: Days
• US Class Current: 514/254.06
• 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 31/131 acyclic
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/335 having oxygen as the only ring hetero atom, e.g. fungichromin
• CPC Class Codes: A61K 31/34 having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
• CPC Class Codes: A61K 31/365 Lactones
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

The invention relates to a method for the treatment of obesity and related diseases comprising the administration of a therapeutically effective amount of Flibanserin.

Claims

1. A method of treating obesity comprising administering to an individual in need thereof a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof.

2. The method according to claim 1 wherein the obesity is selected from the group consisting of exogenic obesity, hyperinsulinaemic obesity, hyperplasmic obesity, hyperphyseal adiposity, hypoplasmic obesity, hypothyroid obesity, hypothalamic obesity, symptomatic obesity, infantile obesity, upper body obesity, alimentary obesity, hypogonadal obesity and central obesity.

12. The method according to claim 2 further comprising administering a second active ingredient selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis.

18. The method according to claim 12, wherein the active substance for the treatment of obesity is selected from the group consisting of orlistat, phenetermine, sibutramine and topiramate or a pharmaceutical acceptable salt thereof.

3. A method of promoting, increasing or facilitating weight loss comprising administering to an individual in need thereof a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof.

13. The method of claim 3 further comprising administering a second active ingredient selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis.

4. A method of inhibiting body weight gain comprising administering to an individual in need thereof a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof.

14. The method of claim 4 further comprising administering a second active ingredient selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis.

5. A method of inhibiting or reducing appetite comprising administering to an individual in need thereof a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof.

15. The method of claim 5 further comprising administering a second active ingredient selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis.

16. The method of claim 5 further comprising the administering a second active ingredient selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis.

17. The method according to claim 16 wherein the diseases and/or disorders associated with obesity are selected from the group consisting of metabolic syndrome (syndromeX), hypertension, osteoarthritis, diabetes, especially type II diabetes, complications of diabetes including diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, insulin resistance, pathological glucose tolerance, encephalorrhagia, heart diseases, cardiac insufficiency, arteriosclerosis, arthritis, gonitis and dyslipidaemia.

6. A method of treating diseases and/or disorders associated with obesity comprising administering to an individual in need thereof a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof.

7. The method according to claim 6 wherein the diseases and/or disorders associated with obesity are selected from the group consisting of metabolic syndrome (syndromeX), hypertension, osteoarthritis, diabetes, especially type II diabetes, complications of diabetes including diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, insulin resistance, pathological glucose tolerance, encephalorrhagia, heart diseases, cardiac insufficiency, arteriosclerosis, arthritis, gonitis and dyslipidaemia.

8. A kit comprising

a) a first pharmaceutical composition comprising an active substance being not flibanserin, selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis,

b) a second pharmaceutical composition comprising flibanserin or a pharmacologically acceptable acid addition salt thereof;

and

c) a container for both compositions.

9. A kit according to claim 8, wherein the active substance of the first pharmaceutical composition is selected from the group consisting of orlistat, phenetermine, sibutramine and topiramate or a pharmaceutical acceptable salt thereof.

10. A pharmaceutical composition comprising

a) an active substance being not flibanserin, selected from the group consisting of active substances for the treatment of diabetes, active substances for the treatment of diabetic complications, active substances for the treatment of obesity, active substances for the treatment of high blood pressure, active substances for the treatment of hyperlipidaemia, including arteriosclerosis active substances for the treatment of dyslipidaemia, including arteriosclerosis, active substances for the treatment of arthritis and

b) flibanserin or a pharmacologically acceptable acid addition salt thereof.

11. A pharmaceutical composition according to claim 10, wherein the active substance for the treatment of obesity is selected from the group consisting of orlistat, phenetermine, sibutramine and topiramate or a pharmaceutical acceptable salt thereof.