Use of flibanserin for the treatment of post-menopausal Sexual Desire Disorders

• US 20070265276A1
• Filed: 05/08/2007
• Published: 11/15/2007
• Est. Priority Date: 05/09/2006
• Status: Abandoned Application

• Current Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Original Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Inventors: PYKE, Robert E., POLLENTIER, Stephane
• Application Number:
  US11/745,515
• Publication Number:
  US 20070265276A1
• Time in Patent Office: Days
• US Class Current: 514/254.60
• 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 15/12 for climacteric disorders
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The invention relates to the use of flibanserin for the preparation of a medicament for the treatment of post-menopausal Sexual Desire Disorders.

Claims

1. ) A method of treating post-menopausal Sexual Desire Disorders (lifelong or acquired) in a woman comprising administering an effective amount of flibanserin, optionally in form of the free base or a pharmacologically acceptable acid addition salt, to a woman in need thereof.

2. ) The method according to claim 1 wherein the flibanserin is in the form of a hydrate and/or solvate thereof.

3. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorder is selected from the group consisting of lifelong post-menopausal Hypoactive Sexual Desire Disorder, lifelong post-menopausal Sexual Aversion Disorder, lifelong post-menopausal loss of sexual desire, lifelong post-menopausal lack of sexual desire, lifelong post-menopausal decreased sexual desire, lifelong post-menopausal inhibited sexual desire, lifelong post-menopausal loss of libido, lifelong post-menopausal libido disturbance, and lifelong post-menopausal frigidity.

4. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorder is selected from the group consisting of lifelong post-menopausal Hypoactive Sexual Desire Disorder, lifelong post-menopausal Sexual Aversion Disorder, lifelong post-menopausal loss of sexual desire, lifelong post-menopausal lack of sexual desire, lifelong post-menopausal decreased sexual desire, and lifelong post-menopausal inhibited sexual desire.

5. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorder is selected from the group consisting of acquired post-menopausal Hypoactive Sexual Desire Disorder, acquired post-menopausal Sexual Aversion Disorder, acquired post-menopausal loss of sexual desire, acquired post-menopausal lack of sexual desire, acquired post-menopausal decreased sexual desire, acquired post-menopausal inhibited sexual desire, acquired post-menopausal loss of libido, acquired post-menopausal libido disturbance, and acquired post-menopausal frigidity.

6. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorder is selected from the group consisting of acquired post-menopausal Hypoactive Sexual Desire Disorder, acquired post-menopausal Sexual Aversion Disorder, acquired post-menopausal loss of sexual desire, acquired post-menopausal lack of sexual desire, acquired post-menopausal decreased sexual desire, acquired post-menopausal inhibited sexual desire.

7. ) The method according claim 1, wherein the post-menopausal Sexual Desire Disorders is of the generalized subtype.

8. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorders is of the situational subtype.

9. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorders is due to psychological factors.

10. ) The method according to claim 1, wherein the post-menopausal Sexual Desire Disorders is due to combined factors.

11. ) The method according to claim 1, wherein flibanserin is administered in form of a pharmaceutically acceptable acid addition salt wherein the salt is formed from an acid selected from the 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.

12. ) The method according to claim 1, wherein flibanserin is administered in form of the free base.

13. ) The method according to claim 12, wherein flibanserin is administered in form of a polymorph A of the free base, having a melting point of about 161°

C. as measured using DSC.

14. ) The method according to claim 1, characterized in that flibanserin is administered in a dosage range between 0.1 to 400 mg per day.

15. ) The method according to claim 1, wherein flibanserin is administered once daily.

16. ) The method of claim 15, wherein flibanserin is adminstered in the evening (50 or 100 mg of flibanserin).

17. ) The method according to claim 1, wherein flibanserin is administered twice daily.

18. ) The method of claim 17, wherein flibanserin is adminstered once in the morning (25 or 50 mg of flibanserin) and once in the evening (25 or 50 mg of flibanserin).