Topical regional neuro-affective therapy with caryophyllene

Abstract

A method of treating a disease state or condition in humans via topical brainstem afferent stimulation therapy via the administration of caryophyllene to the back of the neck of a human patient to provide regional neuro-affective therapy is disclosed. In certain embodiments, the drugs are incorporated into a pharmaceutically acceptable topical carrier, e.g., a cream, gel, lotion or foam.

1 . A method of treating a disease state or condition in human with caryophyllene, comprising administering caryophyllene in a therapeutically effective amount to treat the disease state or condition, to the back of the neck region of a human patient to provide regional neuro-affective therapy to the human patient. 
     
     
         2 . The method of  claim 1 , wherein the back of the neck region comprises the area or region extending from (behind) one ear to the other ear of the human patient and from the back of the head to below the hairline at the back of the neck of the human patient. 
     
     
         3 . The method of  claim 1 , wherein the caryophyllene is administered such that it is absorbed in an area at or above the skin where the afferent components of trigeminal nerve system, cervical sympathetic nerves, and vagus nerve are located. 
     
     
         4 . The method of  claim 1 , wherein the caryophyllene is administered in a topical pharmaceutical formulation in a unit dose containing a therapeutically effective amount of the caryophyllene. 
     
     
         5 . The method of  claim 1 , wherein the caryophyllene is administered in a topical pharmaceutical formulation at the back of the neck at the hairline of the human patient. 
     
     
         6 . The method of  claim 1 , wherein the administration of caryophyllene is selected from the group consisting of topical administration, implantation, transdermal administration, or injection. 
     
     
         7 . The method of  claim 1 , wherein the caryophyllene is β-caryophyllene. 
     
     
         8 . The method of  claim 1 , wherein the caryophyllene is administered in a unit dose comprising from about 3 mg to about 50 mg caryophyllene. 
     
     
         9 . The method of  claim 1 , wherein the caryophyllene is administered in a unit dose comprising from about 15 mg to about 30 mg caryophyllene. 
     
     
         10 . The method of  claim 4 , wherein the unit dose comprises from about 10 mg to about 50 mg caryophyllene and the topical pharmaceutical formulation is in the form of a cream, gel, or foam. 
     
     
         11 . The method of  claim 10 , further comprising administering the topical pharmaceutical formulation from 1 to about 4 times daily. 
     
     
         12 . The method of  claim 10 , wherein the disease state or condition is chronic, further comprising administering a unit dose of the topical pharmaceutical formulation from 1 to about 4 times per day. 
     
     
         13 . The method of  claim 10 , wherein the disease state or condition is acute, further comprising administering a unit dose of the topical pharmaceutical formulation from 1 to about 4 times per day until partial or complete relief is achieved. 
     
     
         14 . The method of  claim 1 , wherein the treatment further comprises further comprises administering to the back of the neck region together simultaneously or sequentially an additional drug(s) selected from the group consisting of an anti-epileptic, an anxiolytic, a neuroleptic, an anti-psychotic, an analgesic, an anti-inflammatory, an anti-Parkinson's disease/syndrome drug, a drug for the treatment of dystonia, a drug for the treatment of spastic conditions, a drug for the treatment of benign essential/familial tremor, a drug for the treatment of tremor related to MS, a drug for the treatment of chronic encepahalopathies, a drug for the treatment of congenital CNS degeneration conditions/cerebral palsy, a drug for the treatment of cerebellar degeneration syndromes, a drug for the treatment of neuropathic and/or neurogenic pain, a drug for appetite suppression, a drug for neurodegenerative conditions, a drug for the treatment of multiple sclerosis, a drug for the treatment of insomnia, a drug for the treatment of fatigue, a drug for the treatment of vertigo, nausea and/or dizziness, a drug for the treatment of writer's cramp and restless leg syndrome, other drugs which can beneficially be added to the treatment in order to provide an additive or synergistic effect with respect to treating the patient's disease state or condition; and a combination of any of the foregoing. 
     
     
         15 . The method of  claim 1 , wherein the treatment further comprises further comprises administering to the back of the neck region together simultaneously or sequentially an additional drug(s) for a condition or disease state selected from the group consisting of anxiety disorder; attention deficit disorder/poor focus; social isolation/autism-related symptoms; muscle tension and spasm; seizures and associated encephalopathy; headache; peripheral neuropathic pain and symptoms thereof; tinnitus/ringing in ears; sinus congestion; skin inflammatory conditions such as actinic keratosis; torticollis, dystonia; arthritis related pain and decreased range of motion; dizziness and light-headedness. 
     
     
         16 . The method of  claim 1 , wherein the patient is treated for a condition or disease state selected from the group consisting of ADD; ADHD; Anxiety Disorder; Cervical Spondylosis; Disc Herniations; Muscle Spasms; Central Pain Syndrome; Central Hypertension; acute pain; peripheral neuropathic pain; R.N. with Chronic Anxiety Disorder; PTSD; MS; seizures; headache; encephalopathy; lethargy; decreased spontaneity; gait disorder; autism; poor focus; tinnitus; myasthenia gravis; torticollis; chronic or acute sinus congestion; Eustachian tube blockage; fibromyalgia; Parkinson's disease; migraine; head or face injury; cervical laminectomy; thoracic laminectomy; lumbar laminectomy; autism; cervical fusion; cerebral palsy; spastic quadriparesis; vertebral artery dissection; posterior fossa stroke: hemiparesis; nystagmus; opsillopsia; dysarthria; failed back syndrome; neonatal nuchal cord syndrome; chronic mood disorder; insomnia; tardive dyskinesia; cervical and/or thoracic compression fracture; lumbar radiculopathy; impulsivity; trigeminal neuralgia; cervical spondylosis; muscle tension headaches; ischemic cerebrovascular disease; eye twitching; lupus cerebritis; normal pressure hydrocephalus; bi-polar affective disorder; depression; and fatigue. 
     
     
         17 . A method of treating a disease state or condition in human, comprising administering a unit dose comprising from about 3 mg to about 50 mg caryophyllene and a second therapeutically active drug to treat the disease state or condition, to the back of the neck region of a human patient to provide regional neuro-affective therapy to the human patient. 
     
     
         18 . The method of  claim 16 , wherein the back of the neck region comprises the area or region extending from (behind) one ear to the other ear of the human patient and from the back of the head to below the hairline at the back of the neck of the human patient. 
     
     
         19 . The method of  claim 16 , wherein the caryophyllene and the second therapeutically active drug are administered such that they are absorbed in an area at or above the skin where the afferent components of trigeminal nerve system, cervical sympathetic nerves, and vagus nerve are located. 
     
     
         20 . The method of  claim 16 , wherein the second therapeutically active drug is selected from a triptan, melatonin, phentermine, an analgesic, 4-AP, apomorphine; a cannabinoid; an ergot alkaloid; a skeletal muscle relaxant; and mixtures of any of the foregoing.