Method for the treatment of drug-induced sexual dysfunction

• US 20060264511A1
• Filed: 05/17/2006
• Published: 11/23/2006
• Est. Priority Date: 05/19/2005
• Status: Abandoned Application

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Pyke, Robert
• Application Number:
  US11/383,793
• Publication Number:
  US 20060264511A1
• Time in Patent Office: Days
• US Class Current: 514/571
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to a method for the treatment of drug-induced sexual dysfunctions comprising the administration of a therapeutically effective amount of flibanserin.

Claims

1. A method for the treatment of a drug-induced sexual dysfunction comprising the administration of a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt thereof, or a hydrate or a solvate thereof.

2. The method for the treatment of a drug-induced sexual dysfunction according to claim 1, wherein the drug-induced sexual dysfunction is selected from the group consisting of drug-induced sexual desire disorders, drug-induced sexual arousal disorders, drug-induced orgasmic disorders, drug-induced sexual pain disorders and combinations thereof.

3. The method according to claim 1, wherein the drug-induced sexual dysfunction is a drug-induced sexual desire disorder.

4. The method according to claim 1, wherein the drug-induced sexual dysfunction is a drug-induced sexual arousal disorder.

5. The method according to claim 1, wherein the drug-induced sexual dysfunction is a drug-induced orgasmic disorder.

6. The method according to claim 1, wherein the drug-induced sexual dysfunction is a drug-induced sexual pain disorder.

7. The method according to claim 1, wherein the sexual dysfunction has been induced by a compound selected from the group consisting of α

-adrenergic receptor antagonists, β

-adrenergic receptor antagonists, calcium channel antagonists, sodium channel antagonists, 5-HT- and/or norepinephrine (NE) -reuptake inhibitors, 5-HT2A antagonists, D2 antagonists, dopamine agonists, Estrogen agonists, progesterone agonists, GABA agonists, HIV protease inhibitors, LH-RH modulators, MAO inhibitors, thiazide diuretics, potassium channel agonists, N-Methyl-D-aspartate (NMDA) receptor antagonists, muscarinic antagonists, Na/K-ATPase inhibitors, H/K-ATPase inhibitors, Histamine H1 or H2 antagonists, androgen antagonists, aldosterone antagonists, calmodulin antagonists, cholinergic receptor blockers, D2 agonists, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitors, progestins, GNRH inhibitors, GNRH analogues, antiestrogens and antiandrogens.

8. The method according to claim 1, wherein the sexual dysfunction has been induced by a compound selected from the group consisting of Prazosin, Clozapine, Mirtazapine, Reboxetine, Clonidine, Guanabenz, Guanethidine, Guanfacine, Guanadrel, Methyldopa, Phenoxibenzamine, Labetalol, Atenolol, Metoprolol, Nadolol, Timolol, Pindolol, Propranolol, Hydralazine, Phenytoin, Nifedipine, Verapamil, Amiodarone, Carbamazepine, Disopyramide, Nefazodone, Amfebutamone, Citalopram, Clomipramine, Fluoxetine, Mianserine, Paroxetine, Sertraline, Trazodone, Amitriptyline, Protriptyline, Amoxapine, Desipramine, Dothiepin, Imipramine, Nortriptyline, Venlafaxine, Reserpine, Fluvoxamine, Ziprasidone, Olanzapine, Droperidol, Metoclopramide, Pimozide, Sulpiride, Quetiapine, Risperidone, Thioridazine, Levodopa, Amineptine, Chlorpromazine, Flupentixol, Fluphenazine, Haloperidol, Perphenazineamitripyline, Levonorgestrel, ethinyl estradiol, Desogestrel, Lynoestrenol, Mestranol, Tamoxifene, Clonazepam, Valproate, Flurazepam, Phenobarbital, Primidone, Indinavir, Nelfinavir, Ritonavir, Saquinavir, Isocarboxazid, Moclobemide, Phenelzine, Tranylcypromine, Bendroflumethiazide, Chlortalidone, Hydrochlorothiazide, Trichlormethiazide, Indapamide, Minoxidil, Amantadine, Atropine, Bethanechol chloride, Digitalis, Digoxin, Esomeprazole, Doxepin, Cimetidine, Cyproterone acetate, Spironolactone, Trifluoperazine, Benzatropine, Bromocriptine, Reserpine, Triamterene, Stanozolol, Gemfibrozil, Disulfiram Lovastatin, Rosuvastatin, Fluvastatin, lovastatin, Atorvastatin, Simvastatin, Norethindrone, Norgestimate, Norgestrel, Drospirenone, Medroxyprogesterone, Abarelix, Triptorelin, Leuprolide, Anastrozol, Exemestane, Toremifine, Letrozole, Fulvestrant, Bicalutamide, Flutamide, or combination thereof.

9. The method according to claim 1, wherein flibanserin is in the form of a pharmaceutically acceptable acid addition salt wherein the pharmaceutically acceptable acid addition salt is formed by an acid selected from group consisting of succinic acid, hydrobromic acid, acetic acid, fumaric acid, maleic acid, methanesulphonic acid, lactic acid, phosphoric acid, hydrochloric acid, sulphuric acid, tartaric acid, citric acid, and mixtures thereof.

10. The method according to claim 1, wherein flibanserin is in the form of flibanserin polymorph A.

11. A kit comprising

a) a first pharmaceutical composition comprising an active ingredient, which has the side effect of causing a sexual dysfunction, for the treatment of an underlying disease;

b) a second pharmaceutical composition comprising flibanserin, or a pharmacologically acceptable acid addition salt thereof, or a hydrate or solvate thereof, for the treatment of the a sexual dysfunction induced by the active ingredient of the first pharmaceutical composition; and

c) a container for both compositions.

12. A pharmaceutical composition comprising a) an active ingredient which causes a sexual dysfunction as a side effect and b) flibanserin, or a pharmacologically acceptable acid addition salt thereof, or a hydrate or solvate thereof.