Use of flibanserin for the treatment of pre-menopausal sexual desire disorders

1 ) A method of treating pre-menopausal sexual desire disorders comprising administering an effective amount of flibanserin to a female in need thereof, wherein flibanserin is in form of the free base or a pharmacologically acceptable acid addition salt, and wherein flibanserin is optionally in the form of a hydrate and/or solvate thereof.

2 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is selected from the group consisting of pre-menopausal hypoactive sexual desire disorder, pre-menopausal sexual aversion disorder, pre-menopausal loss of sexual desire, pre-menopausal lack of sexual desire, pre-menopausal decreased sexual desire, pre-menopausal inhibited sexual desire, pre-menopausal loss of libido, pre-menopausal libido disturbance, and pre-menopausal frigidity.

3 ) The method according to claim 2 , wherein the pre-menopausal sexual desire disorder is selected from the group consisting of pre-menopausal hypoactive sexual desire disorder, pre-menopausal sexual aversion disorder, pre-menopausal loss of sexual desire, pre-menopausal lack of sexual desire, pre-menopausal decreased sexual desire, and pre-menopausal inhibited sexual desire.

4 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is of lifelong type.

5 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is of acquired type.

6 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is of the generalized subtype.

7 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is of the situational subtype.

8 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is due to psychological factors.

9 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is due to organic factors.

10 ) The method according to claim 1 , wherein the pre-menopausal sexual desire disorder is due to combined factors.

11 ) 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 selected from the salts formed by the acids 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 in form of its free base.

13 ) The method according to claim 12 , wherein flibanserin is 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 , wherein flibanserin is administered with a dosage in the range between 0.1 to 400 mg per day.

15 ) The method according to one claim 1 , wherein flibanserin is administered once or twice daily consecutively over a period of time.

16 ) The method according to claim 1 , wherein flibanserin is administered in the morning and the evening.

17 ) The method according to claim 16 , wherein flibanserin is administered once in the morning with a dosage of 25 or 50 mg of flibanserin, and once in the evening with a dosage of 25 or 50 mg of flibanserin.

18 ) The method according to claim 1 , wherein flibanserin is administered once in the evening only with a dosage of 50 or 100 mg of flibanserin, consecutively over a period of time.