Details for Patent: 7,115,631

Title:	Methods for treatment of cognitive and menopausal disorders with D-threo methylphenidate
Abstract:	In one aspect, the present invention is directed to methods for treating fatigue, neurobehavioral slowing and other cognitive disorders and defects due to cancers and treatments associated with cancers, and similar conditions. In a further aspect, the present invention is directed to methods for treating disorders related to menopause, including executive function defects. The methods involve the administration of a composition comprising D-threo methylphenidate that is substantially free of L-threo methylphenidate and of erythro forms of methylphenidate.
Inventor(s):	Zeldis; Jerome B (Princeton, NJ), Faleck; Herbert J. (West Orange, NJ), Khetani; Vikram (Short Hills, NJ), Zeitlin; Andrew L. (Basking Ridge, NJ), Dariani; Maghsoud M. (Fanwood, NJ), Sterling; David (Branchburg, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Filing Date:	Jul 16, 2002
Application Number:	10/195,974
Claims:	1. A method for alleviating fatigue arising from an oncological condition, said method comprising the steps of: identifying a patient suffering from said fatigue, and administering to said patient a unit dosage comprising a compound having the formula ##STR00002## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 2. The method of claim 1 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 3. The method of claim 1 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 4. The method of claim 1 wherein the unit dosage is in a form suitable for oral administration. 5. The method of claim 1 wherein said oncological condition is a cancer selected from the group consisting of solid tumors and nonsolid tumors. 6. The method of claim 1 wherein said oncological condition is a solid tumor. 7. A method for alleviating fatigue arising from the administration of a treatment for an oncological condition, said method comprising the steps of: identifying a patient suffering from said fatigue, and administering to said patient a unit dosage comprising a compound having the formula ##STR00003## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 8. The method of claim 7 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 9. The method of claim 7 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 10. The method of claim 7 wherein the unit dosage is in a form suitable for oral administration. 11. The method of claim 7 wherein said treatment for said oncological condition is chemotherapy or radiation therapy. 12. The method of claim 7 wherein said treatment for said oncological condition is chemotherapy. 13. A method for alleviating neurobehavioral slowing arising from an oncological condition, said method comprising the steps of: identifying a patient suffering from said neurobehavioral slowing, and administering to said patient a unit dosage comprising a compound having the formula ##STR00004## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 14. The method of claim 13 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 15. The method of claim 13 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 16. The method of claim 13 wherein the unit dosage is in a form suitable for oral administration. 17. The method of claim 13 wherein said oncological condition is a cancer selected from the group consisting of solid tumors and nonsolid tumors. 18. The method of claim 13 wherein said oncologicaI condition is a solid tumor. 19. A method for alleviating neurobehavioral slowing arising from the administration of a treatment for an oncological condition, said method comprising the steps of: identifying a patient suffering from said neurobehavioral slowing, and administering to said patient a unit dosage comprising a compound having the formula ##STR00005## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 20. The method of claim 19 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 21. The method of claim 19 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 22. The method of claim 19 wherein the unit dosage is in a form suitable for oral administration. 23. The method of claim 19 wherein said treatment for said oncological condition is chemotherapy or radiation therapy. 24. The method of claim 19 wherein said treatment for said oncological condition is chemotherapy. 25. The method of claim 19 wherein said oncological condition is a cancer selected from the group consisting of solid tumors and nonsolid tumors. 26. The method of claim 19 wherein said oncological condition is a solid tumor. 27. A method for alleviating a cognitive side effect of a treatment for an oncological condition, comprising the steps of: identifing a patient suffering from a cognitive side-effect of a treatment for an oncological condition; and administering to said patient a unit dosage comprising a compound having the formula ##STR00006## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 28. The method of claim 27 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 29. The method of claim 27 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 30. The method of claim 27 wherein the unit dosage is in a form suitable for oral administration. 31. The method of claim 27 wherein said oncological condition is a cancer selected from the group consisting of solid tumors and nonsolid tumors. 32. The method of claim 27 wherein said oncological condition is a solid tumor. 33. The method of claim 27 wherein said treatment for said oncological condition is the administration of pain relief medication, chemotherapy, radiation therapy, or surgery. 34. The method of claim 27 wherein said treatment for said oncological condition is the administration of pain relief medication. 35. The method of claim 34 wherein said pain relief medication is and opioid analgesic. 36. The method of claim 27 wherein said cognitive side effect is sedation, decreased cognitive function, major depressive disorder, or neurobehavioral slowing. 37. The method of claim 36 wherein said cognitive side effect is sedation, decreased cognitive function or neurobehavioral slowing. 38. The method of claim 36 wherein said cognitive side effect is sedation. 39. A method for treating a symptom of menopause comprising the steps of: identifing a patient suffering from a symptom of menopause; and administering to said patient a unit dosage comprising a compound having the formula ##STR00007## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 is C.sub.1-C.sub.4 alkyl, and R.sub.2 is hydrogen or C.sub.1-C.sub.4 alkyl, in a pharmaceutically acceptable carrier or diluent, said dosage having less than 10% by weight of other stereoisomers of the compound or salt. 40. The method of claim 39 wherein the unit dosage is 1% to about 90% by weight of active ingredient. 41. The method of claim 39 wherein the unit dosage is 20% to about 90% by weight of active ingredient. 42. The method of claim 39 wherein the unit dosage is in a form suitable for oral administration. 43. The method of claim 39 wherein said symptom of menopause is decreased cognitive function. 44. The method of claim 39 wherein said symptom of menopause is vasomotor instability. 45. The method of claim 39 wherein said symptom of menopause is nervousness. 46. The method of claim 39 wherein said symptom of menopause is mental depression. 47. The method of claim 39 wherein said symptom of menopause is excitability. 48. The method of claim 39 wherein said symptom of menopause is fatigue. 49. The method of claim 39 wherein said symptom of menopause is apathy. 50. The method of claim 39 wherein said symptom of menopause is impairment of short term memory. 51. The method of claim 1 wherein said administration of said compound gives rise to efficacious treatment without interfering with patient sleep patterns or engendering anoretic behavior. 52. The method of claim 7 wherein said administration of said compound gives rise to efficacious treatment without interfering with patient sleep pattern or engendering anoretic behavior. 53. The method of claim 13 wherein said administration of said compound gives rise to efficacious treatment without nterfering with patient sleep patterns or engendering anoretic behavior. 54. The method of claim 19 wherein said administration of said compound gives rise to efficacious treatment without interfering with patient sleep patterns or engendering anoretic behavior. 55. The method of claim 27 wherein said administration of said compound gives rise to efficacious treatment without interfering with patient sleep patterns or engendering anoretic behavior. 56. The method of claim 39 wherein said administration of said compound gives rise to efficacious treatment without interfering with patient sleep patterns or engendering anoretic behavior.