Cytokine antagonists for neurological and neuropsychiatric disorders
First Claim
1. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
- a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-l) (Serono); and
b) administering said dose parenterally by perispinal administration.
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Accused Products
Abstract
Methods for treating neurological or neuropsychiatric diseases or disorders in humans by administering to the human a therapeutically effective dose of specific biologics are presented. The biologics of consideration include antagonists of tumor necrosis factor or of interleukin-1. The administration of these biologics is performed by specific methods, most, but not all of which fall into the category of anatomically localized administration designed for perispinal use. Anatomically localized administration involving perispinal use includes, but is not limited to the subcutaneous, intramuscular, interspinous, epidural, peridural, parenteral or intrathecal routes. Additonally, intranasal administration is discussed as a method to provide therapeutic benefit.
The clinical conditions of consideration include, but are not limited to the following: diseases of the brain, including neurodegenerative diseases such as Alzheimer'"'"'s Disease and Parkinson'"'"'s Disease; migraine headache; spinal radiculopathy associated with intervertebral disc herniation, post-herpetic neuralgia, reflex sympathethic dystrophy, neuropathic pain, vertebral disc disease, low back pain, amyotrophic lateral sclerosis, chronic fatigue syndrome; and neuropsychiatric diseases, including bipolar affective disorder, anorexia nervosa, nicotine withdrawal, narcotic addiction, alcohol withdrawl, postpartum depression, and schizoaffective illness.
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Citations
59 Claims
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1. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-l) (Serono); and
b) administering said dose parenterally by perispinal administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for treating neurological diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method for treating neurological diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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26. A method for treating nerve root inflammation in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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27. A method for treating Alzheimer'"'"'s Disease in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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28. A method for treating Parkinson'"'"'s Disease in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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29. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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30. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose by intranasal administration. - View Dependent Claims (40)
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31. A method for treating anorexia nervosa in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the step of:
a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono).
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32. A method for treating anorexia nervosa in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
- a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose by intranasal administration.
- a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
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33. A method for treating anorexia nervosa in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose by perispinal administration.
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34. A method for treating neurological or neuropsychiatric diseases in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of infliximab comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said infliximab; and
b) administering said dose parenterally by perispinal administration.
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35. A method for treating neurological or neuropsychiatric diseases in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of onercept comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said onercept; and
b) administering said dose parenterally by perispinal administration.
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36. A method for treating neurological or neuropsychiatric diseases in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of etanercept comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said etanercept; and
b) administering said dose parenterally by perispinal administration.
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37. A method for treating neurological or neuropsychiatric diseases in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of D2E7 comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said D2E7; and
b) administering said dose parenterally by perispinal administration.
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38. A method for treating neurological or neuropsychiatric diseases in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of CDP 870 comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said CDP 870; and
b) administering said dose parenterally by perispinal administration.
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39. A method for treating neurological or neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and
,b) administering said dose parenterally by perispinal administration.
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41. A method for treating low back pain in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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42. A method for treating fibromyalgia in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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43. A method for treating vertebral disc disease in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration using the interspinous route.
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44. A method for treating vertebral disc disease in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration.
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45. A method for treating low back pain in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration.
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46. A method for treating neurological diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of onercept, a recombinant TNF binding protein (r-TBP-1) (Serono) comprising the step of:
a) administering a therapeutically effective dosage level to said human of said onercept.
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47. A method for treating nicotine withdrawal in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration.
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48. A method for treating nicotine withdrawal in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose by intranasal administration.
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49. A method for treating narcotic addiction in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration.
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50. A method for treating migraine headache in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b) administering said dose parenterally by perispinal administration.
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51. A method for treating neurological diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and
b) administering said dose by perispinal administration.
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52. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and
b) administering said dose by perispinal administration.
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53. A method for treating neurological diseases or disorders in a human by inhibiting the action of interleukin-1 (IL-1) through the administration of a IL-1 antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said IL-1 antagonist; and
b) administering said dose by perispinal administration.
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54. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of interleukin-1 (IL-1) through the administration of a IL-1 antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said IL-1 antagonist; and
b) administering said dose by perispinal administration.
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55. A method for treating neurological diseases or disorders in a human by inhibiting the action of interleukin-1 (IL-1) through the administration of a IL-1 antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said IL-1 antagonist selected from the group consisting of IL-1 receptor antagonist;
Kineret (Amgen);
IL-1 Receptor type 2 (Amgen);
AMG719 (Amgen) and IL-1 Trap (Regeneron); and
b) administering said dose parenterally by perispinal administration.
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56. A method for treating neuropsychiatric diseases or disorders in a human by inhibiting the action of interleukin-1 (IL-1) through the administration of a IL-1 antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said IL-1 antagonist selected from the group consisting of IL-1 receptor antagonist;
Kineret (Amgen);
IL-1 Receptor type 2 (Amgen);
AMG719 (Amgen) and IL-1 Trap (Regeneron); and
b) administering said dose parenterally by perispinal administration.
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57. A method for treating alcohol withdrawal in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b). administering said dose by intranasal administration.
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58. A method for treating narcotic addiction in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b). administering said dose by intranasal administration.
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59. A method for treating alcohol withdrawal in a human by inhibiting the action of tumor necrosis factor (TNF) through the administration of a TNF antagonist comprising the steps of:
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a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, pegylated soluble TNF receptor Type I (PEGs TNF-R
1) and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and
b). administering said dose parenterally by perispinal administration.
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Specification