Claims for Patent: 6,982,089

Summary for Patent: 6,982,089

Title:	Cytokine antagonists for neurological and neuropsychiatric disorders
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.
Inventor(s):	Tobinick; Edward Lewis (Los Angeles, CA)
Assignee:	TACT IP, LLC (Highland Beach, FL)
Application Number:	10/269,745
Patent Claims:	1. A method for treating TNF mediated dementias, being Alzheimer's Disease, Pick's Disease, Lewy Body Disease and Idiopathic Dementia, 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, 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 into the perispinal space without direct intrathecal injection. 2. A method for treating in accordance with claim 1, wherein the step of administering said TNF antagonist is performed through any of the following routes: subcutaneous, intramuscular, interspinous, parenteral, or epidural. 3. A method for treating spinal cord injury 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, 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 into the perispinal space without direct intrathecal injection. 4. A method for treating TNF mediated pain syndromes, being Migraine Headaches, Cluster Headaches, Neuropathic Pain, Fibromyalgia, Post-Herpetic Neuralgia and Reflex Sympathetic Dystrophy (RSD) 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, 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 into the perispinal space without direct intrathecal injection. 5. A method for treating TNF mediated back pain syndromes being Lumbar and Cervical Radiculopathy, Low Back Pain and 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, 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 into the perispinal space without direct intrathecal injection. 6. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 7. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting, of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 8. 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: a) administering a therepeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 9. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 10. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection. 11. 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: 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), 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 into the perispinal space without direct intrathecal injection using the interspinous route. 12. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, and onercept, a recombinant TNF binding protein (r-TBP-1) (Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 13. 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: a) administering a therapeutically effective dosage level to said human of said TNF antagonist; selected from tho group consisting of soluble TNF receptor Type I and pegylated soluble TNF receptor Type I; and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route. 14. A method for treating in accordance with claim 5, wherein the step of administering said TNF antagonist is performed through any of the following routes: subcutaneous, intramuscular, interspinous, parenteral, or epidural. 15. A method for treating Neuropathic Pain 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, and onercept, a recombinant TNF binding protein (r-TBP-1) Serono); and b) administering said dose parenterally by perispinal administration into the perispinal space without direct intrathecal injection using the interspinous route.

Details for Patent 6,982,089

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2019-02-24
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2019-02-24
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2019-02-24