Treatment of vasomotor symptoms

• US 10,166,230 B2
• Filed: 12/26/2014
• Issued: 01/01/2019
• Est. Priority Date: 09/12/2007
• Status: Active Grant

• Current Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Original Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Inventors: Hanes, Vladimir, Verbeek, Anna Elizabeth
• Primary Examiner(s): West, Theodore R
• Application Number:
  US14/583,275
• Publication Number:
  US 20150250783A1
• Time in Patent Office: 1,467 Days
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61P 15/12 for climacteric disorders

Abstract

The invention relates to a method for the treatment of vasomotor symptoms comprising the administration of a therapeutically effective amount of flibanserin.

Claims

1. A method for the treatment of vasomotor symptoms associated with menopause comprising the administration to a patient in need of such treatment a therapeutically effective amount of flibanserin, or a pharmacologically acceptable acid addition salt, hydrate or solvate, thereof, wherein said vasomotor symptoms are selected from the group consisting of night sweats, mood swings, and irritability.

2. The method according to claim 1, wherein the vasomotor symptoms are night sweats.

3. The method according to claim 1, wherein the vasomotor symptoms are mood swings.

4. The method according to claim 1, wherein the vasomotor symptoms are irritability.

5. The method according to claim 1, wherein menopause is naturally occurring.

6. The method according to claim 1, wherein menopause is surgically induced.

7. The method according to claim 1, wherein menopause is iatrogenic induced.

8. The method according to claim 1, wherein menopause is associated with the use of medication, radiation, or chemotherapeutic agents.

9. The method according to claim 1, wherein the flibanserin is administered as a pharmaceutically acceptable acid addition salt selected from the salts formed by 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 the patient is a menopausal woman.

11. The method according to claim 1, wherein the patient is a postmenopausal woman.

12. The method according to claim 1, wherein the patient is a perimenopausal woman.

13. The method according to claim 1, wherein the flibanserin is administered in a dose range between 0.1 to 400 mg per day.

14. The method according to claim 1, wherein the flibanserin is administered in a dose range between 1.0 and 300 mg per day.

15. The method according to claim 1, wherein the flibanserin is administered in a dose range between 2 and 200 mg per day.

16. The method according to claim 1, wherein the flibanserin is administered in a dose range between 0.01 to 100 mg per day.

17. The method according to claim 1, wherein the flibanserin is administered in a dose range between 0.1 to 50 mg per day.