Claims for Patent: 9,278,096

Summary for Patent: 9,278,096

Title:	Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity
Abstract:	New pharmaceutical uses of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine and pharmaceutically acceptable salts thereof are provided.
Inventor(s):	Dragheim; Marianne (Vedbaek, DK)
Assignee:	H. Lundbeck A/S (Valby, DK) Takeda Pharmaceuticals North America, Inc. (Deerfield, IL)
Application Number:	12/741,780
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,278,096
Patent Claims:	1. A method for the treatment of a disease selected from the group consisting of depression, anxiety, abuse and chronic pain, comprising the administration of a therapeutically effective amount of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Compound I) or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein said patient has previously received medication or is still receiving medication for the treatment of said disease, the medication is ceased or reduced or has to be ceased or reduced due to sexually related adverse events, and the medication is selected from the group consisting of selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, noradrenaline/serotonin reuptake inhibitors, and tri-cyclics. 2. The method of claim 1, wherein said patient is still receiving said medication for treatment of said disease. 3. The method according to claim 1, wherein said patient is administered the hydrobromic acid salt of Compound I. 4. The method according to claim 3, wherein said salt is crystalline and characterized by having major x-ray powder diffraction (XRPD) peaks at 6.89, 9.73, 13.78 and 14.62 (.degree.2.theta.), all .+-.0.1 (.degree.2.theta.). 5. The method according to claim 4, wherein said salt is characterized by an XRPD pattern as depicted in FIG. 3. 6. The method according to claim 1, wherein Compound I or a pharmaceutically acceptable salt thereof is administered to the patient in unit doses of about 1-50 mg. 7. The method according to claim 6, wherein the patient is administered between about 1 and 20 mg per day of the hydrobromic acid salt of Compound I orally. 8. The method according to claim 1, wherein said patient is administered a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof, provided it is not the free base of Compound I in a non-crystalline form. 9. A method for the treatment of a disease selected from the group consisting of depression, anxiety, abuse and chronic pain, comprising the administration of a therapeutically effective amount of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Compound I) or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein said patient has previously received medication or is still receiving medication for the treatment of said disease, the medication is ceased or reduced or has to be ceased or reduced due to sleep related adverse events, and the medication is selected from the group consisting of selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, noradrenaline/serotonin reuptake inhibitors, and tri-cyclics. 10. The method of claim 9, wherein said patient is still receiving said medication for treatment of said disease. 11. The method of claim 9, wherein said patient is administered the hydrobromic acid salt of Compound I. 12. The method of claim 11, wherein said salt is crystalline and characterized by having major x-ray powder diffraction (XRPD) peaks at 6.89, 9.73, 13.78 and 14.62 (.degree.2.theta.), all .+-.0.1 (.degree.2.theta.). 13. The method of claim 12, wherein said salt is characterized by an XRPD pattern as depicted in FIG. 3. 14. The method of claim 9, wherein Compound I or a pharmaceutically acceptable salt thereof is administered to the patient in unit doses of about 1-50 mg. 15. The method of claim 14, wherein the patient is administered between about 1 and 20 mg per day of the hydrobromic acid salt of Compound I orally. 16. The method of claim 9, wherein said patient is administered a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof, provided it is not the free base of Compound I in a non-crystalline form. 17. The method of claim 1, wherein the medication is selected from the group consisting of selective serotonin reuptake inhibitors and selective noradrenaline reuptake inhibitors. 18. The method of claim 17, wherein the medication is selected from the group consisting of selective serotonin reuptake inhibitors. 19. The method of claim 18, wherein the disease is depression. 20. The method of claim 19, wherein the method comprises administering to the patient between about 1 and 20 mg per day of the hydrobromic acid salt of Compound I. 21. The method of claim 20, wherein the method comprises administering to the patient between about 5 and 10 mg per day of the hydrobromic acid salt of Compound I. 22. The method of claim 9, wherein the medication is selected from the group consisting of selective serotonin reuptake inhibitors and selective noradrenaline reuptake inhibitors. 23. The method of claim 22, wherein the medication is selected from the group consisting of selective serotonin reuptake inhibitors. 24. The method of claim 23, wherein the disease is depression. 25. The method of claim 24, wherein the method comprises administering to the patient between about 1 and 20 mg per day of the hydrobromic acid salt of Compound I. 26. The method of claim 25, wherein the method comprises administering to the patient between about 5 and 10 mg per day of the hydrobromic acid salt of Compound I.