Methods for treatment of cognitive and menopausal disorders with D-threo methylphenidate

• US 20040204456A1
• Filed: 04/08/2004
• Published: 10/14/2004
• Est. Priority Date: 12/04/1995
• Status: Abandoned Application

• Current Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Dariani, Magsoud M., Zeldis, Jerome B., Khetani, Vikram, Zeitlin, Andrew L., Faleck, Herbert J., Sterling, David I.
• Application Number:
  US10/820,397
• Publication Number:
  US 20040204456A1
• Time in Patent Office: Days
• US Class Current: 514/317
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C07D 211/34 with hydrocarbon radicals, substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
• CPC Class Codes: C12P 17/12 containing a six-membered hetero ring
• CPC Class Codes: C12P 41/006 by reactions involving C-N bonds, e.g. nitriles, amides, hydantoins, carbamates, lactames, transamination reactions, or keto group formation from racemic mixtures

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.

Claims

1-46. -46. (canceled)

47. A method of alleviating a cognitive side effect due to cancer or a treatment for cancer comprising:

identifying a patient suffering from said side effect, and

administrating a therapeutically effective amount of D-threo methylphenidate to said patient in a pulsatile release dosage form.

48. The method of claim 47 wherein said D-threo methylphenidate is in the form of a pharmaceutically acceptable salt.

49. The method of claim 47 wherein said cancer is a solid tumor or nonsolid tumor.

50. The method of claim 49 wherein said cancer is a solid tumor.

51. The method of claim 47 wherein said treatment comprises chemotherapy or radiation therapy.

52. The method of claim 47 wherein said dosage form comprises a pharmaceutically acceptable carrier.

53. The method of claim 52 wherein said carrier is a tablet or a capsule.

54. The method of claim 47 wherein said administration is by oral dosage form.

55. The method of claim 47 wherein said side effect comprises sedation, neurobehavioral slowing, decreased cognitive function, depression, apathy, decreased libido, or depersonalization.

56. A method of alleviating a cognitive side effect due to cancer or a treatment for cancer comprising:

identifying a patient suffering from said side effect, and

administrating a therapeutically effective amount of D-threo methylphenidate to said patient in a chronic, bolus dosage form.

57. The method of claim 56 wherein said D-threo methylphenidate is in the form of a pharmaceutically acceptable salt.

58. The method of claim 56 wherein said cancer is a solid tumor or nonsolid tumor.

59. The method of claim 58 wherein said cancer is a solid tumor.

60. The method of claim 56 wherein said treatment comprises chemotherapy or radiation therapy.

61. The method of claim 56 wherein said dosage form comprises a pharmaceutically acceptable carrier.

62. The method of claim 61 wherein said carrier is a solution, suspension, tablet, capsule, ointment, elixir, or injectable composition.

63. The method of claim 56 wherein said administration is by oral dosage form, injection, or infusion.

64. The method of claim 56 wherein said side effect comprises sedation, neurobehavioral slowing, decreased cognitive function, depression, apathy, decreased libido, or depersonalization.

65. A method of alleviating a cognitive side effect due to cancer or a treatment for cancer comprising:

identifying a patient suffering from said side effect, and

administrating a therapeutically effective amount of D-threo methylphenidate to said patient in a time release dosage form.

66. The method of claim 65 wherein said D-threo methylphenidate is in the form of a pharmaceutically acceptable salt.

67. The method of claim 65 wherein said cancer is a solid tumor or nonsolid tumor.

68. The method of claim 67 wherein said cancer is a solid tumor.

69. The method of claim 65 wherein said treatment comprises chemotherapy or radiation therapy.

70. The method of claim 65 wherein said dosage form comprises a pharmaceutically acceptable carrier.

71. The method of claim 70 wherein said carrier is a solution, suspension, tablet, or a capsule.

72. The method of claim 65 wherein said administration is by oral dosage form, injection, or infusion.

73. The method of claim 65 wherein said side effect comprises sedation, neurobehavioral slowing, decreased cognitive function, depression, apathy, decreased libido, or depersonalization.

74. A method of alleviating a cognitive side effect of chemotherapy comprising:

identifying a patient suffering from said side effect, and

administrating a therapeutically effective amount of D-threo methylphenidate following the end of at least one cycle of chemotherapy.

75. The method of claim 74 wherein said D-threo methylphenidate is in the form of a pharmaceutically acceptable salt.

76. The method of claim 74 wherein said administration is by oral dosage form, injection, infusion, or pharmaceutically acceptable carrier.

77. The method of claim 76 wherein said carrier is a solution, suspension, tablet, capsule, ointment, elixir, or injectable composition.

78. The method of claim 74 wherein said side effect comprises sedation, neurobehavioral slowing, decreased cognitive function, depression, apathy, decreased libido or depersonalization.