Treating sexual desire disorders with flibanserin

• US 10,675,280 B2
• Filed: 05/14/2019
• Issued: 06/09/2020
• Est. Priority Date: 10/20/2001
• Status: Expired due to Term

• Current Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Original Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Inventors: Borsini, Franco, Evans, Kenneth Robert
• Primary Examiner(s): Love, Trevor
• Application Number:
  US16/412,009
• Publication Number:
  US 20190262336A1
• Time in Patent Office: 392 Days
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin

Abstract

The invention relates to the use of flibanserin, or a pharmaceutically acceptable acid addition salt thereof, for the treatment of disorders of sexual desire.

Claims

1. A method of treating a female hypoactive sexual desire disorder in a human adult patient, comprising orally administering a therapeutically effective amount of flibanserin to the patient to treat the female hypoactive sexual desire disorder.

2. The method according to claim 1, wherein the amount administered is between about 0.1 mg and 400 mg per day of flibanserin.

3. The method according to claim 1, wherein the amount administered is between about 1 mg and 300 mg per day of flibanserin.

4. The method according to claim 1, wherein the amount administered is in a dosage unit containing between about 0.01 mg and 100 mg of flibanserin.

5. The method according to claim 1, wherein the amount administered is in a dosage unit containing about 100 mg.

6. A method of treating a female hypoactive sexual desire disorder in a human adult patient, comprising orally administering a tablet comprising a therapeutically effective amount of flibanserin to the patient to treat the female hypoactive sexual desire disorder.

7. The method according to claim 6, wherein the amount administered is between about 0.1 mg and 400 mg per day of flibanserin.

8. The method according to claim 6, wherein the tablet comprises about 0.01 mg to 100 mg of flibanserin.

9. The method according to claim 6, wherein the tablet comprises about 100 mg flibanserin.

10. The method according to claim 6, wherein the tablet further comprises one or more excipients or carriers.

11. The method according to claim 10, wherein the one or more excipients or carriers comprise at least one inert diluent.

12. The method according to claim 11, wherein the at least one inert diluent is selected from calcium carbonate, calcium phosphate, lactose, and combinations thereof.

13. The method according to claim 10, wherein the one or more excipients or carriers comprise at least one lubricant.

14. The method according to claim 13, wherein the at least one lubricant is selected from the group consisting of magnesium stearate, talc, and combinations thereof.

15. The method according to claim 10, wherein the one or more excipients or carriers comprise at least one distintegrant.

16. The method according to claim 15, wherein the at least one disintegrant is selected from corn starch, alginic acid, and combinations thereof.

17. The method according to claim 10, wherein the one or more excipients or carriers comprise at least one binder.

18. The method according to claim 17, wherein the at least one binder is selected from starch, gelatin, and combinations thereof.

19. The method according to claim 10, wherein the one or more excipients or carriers comprise at least one agent for delaying release.

20. The method according to claim 19, wherein the at least one agent for delaying release is selected from carboxymethyl cellulose, cellulose acetate phthalate, polyvinyl acetate, and combinations thereof.

21. The method according to claim 6, wherein the tablet further comprises one or more sweeteners, one or more flavor enhancers, preservatives, or a combination thereof.

22. The method according to claim 6, wherein the tablet further comprises magnesium stearate, talc, and microcrystalline cellulose.

23. The method according to claim 22, wherein the tablet further comprises one or both of lactose and sodium-carboxymethyl starch.

24. The method according to claim 10, wherein the tablet comprises a compressed mixture of flibanserin and the one or more excipients or carriers.

25. The method according to claim 6, wherein the tablet is uncoated.