THATTHE TOUT UNTUKUAUS 20180049994A1AUTOMATION UNIT HI HA HINTHI (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2018 / 0049994 A1 Aung -Din (43 ) Pub . Date : Feb . 22 , 2018 ( 54 ) TOPICAL REGIONAL NEURO -AFFECTIVE A61K 31/ 473 (2006 .01 ) THERAPY WITH CARYOPHYLLENE A61K 31/ 137 (2006 .01 ) A61K 31 / 165 ( 2006 .01 ) (71 ) Applicant : Afgin Pharma , LLC , Sarasota , FL A61K 31/ 4409 (2006 .01 ) (US ) A61K 31/ 404 ( 2006 . 01 ) 52 ) U . S . CI. ( 72 ) Inventor : Ronald Aung -Din , Sarasota , FL (US ) CPC .. .. .. A61K 31 /015 (2013 . 01 ) ; A61K 9 /0014 ( 2013 .01 ) ; A61K 45 / 06 ( 2013 .01 ) ; A61K ( 73 ) Assignee : Afgin Pharma, LLC , Sarasota , FL 31/ 4045 ( 2013 .01 ) ; A61K 31/ 404 ( 2013 .01 ) ; (US ) A61K 31 / 137 (2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; A61K 31 /4409 ( 2013 .01 ) ; A61K (21 ) Appl. No. : 15 / 238 , 118 31/ 473 ( 2013. 01 ) ( 22 ) Filed : Aug. 16, 2016 (57 ) ABSTRACT A method of treating a disease state or condition in humans Publication Classification via topical brainstem afferent stimulation therapy via the (51 ) Int. CI. administration of caryophyllene to the back of the neck of a A61K 31 /015 (2006 .01 ) human patient to provide regional neuro -affective therapy is A61K 9 / 00 ( 2006 .01 ) disclosed . In certain embodiments , the drugs are incorpo A61K 45 / 06 ( 2006 .01 ) rated into a pharmaceutically acceptable topical carrier , e . g . , A61K 31 /4045 ( 2006 .01 ) a cream , gel , lotion or foam . US 2018 / 0049994 A1 Feb . 22 , 2018 TOPICAL REGIONAL NEURO - AFFECTIVE effects created much mis - information and labeling as " gate THERAPY WITH CARYOPHYLLENE way drug . ” There is no class of compound with more controversy and stigma than cannabis . In 1937 , US Con FIELD OF THE INVENTION gress enacted cannabis prohibition , soon after alcohol pro hibition was lifted . [ 0001 ] The invention relates to topical regional neuro [0006 ] There is no greater example of a " double - edged affective therapy (“ TRNA THERAPY " ) with a caryophyl sword ” in medical therapeutics than medical marijuana . lene ( s ) . This is accomplished via administration of effective While benefits for treating symptoms of diverse neurologic amounts of these agents on the back of the neck . and psychiatric conditions have been known and practiced by ancient civilizations for thousands of years , marijuana ' s BACKGROUND OF THE INVENTION psychoactive effects have also led to abuse and labeling as [0002 ] The approximate 21/ 2 pound human brain is com a “ gateway drug " for more addictive compounds . There is prised of the most complex material known to man . The no class of therapeutic compounds with more controversy neuron , the primary functional cell of the nervous system , and stigma than cannabinoids , active components of the operates on the basis of electrical impulses that result in the cannabis plant. release of neurochemical substances ( neurotransmitters ) at [ 0007 ] The U . S . Government has indicated there is no specific receptors : dopamine , serotonin , acetylcholine , nor medical benefit for marijuana and classified it Controlled epinephrine , gamma -amino butyric acid (GABA ), and many Substance Category 1 , as heroin . It is considered by federal others . There are estimated to be 80 - 100 billion ( 10 times the law , illegal to possess or use cannabis and its associated world population ) neurons in the average human brain . products . However, increasing number of states have chal These neurons, in turn , make 200 - 300 billion coded con lenged this position and legalized cannabis within their nections with other neurons to accomplish the complex tasks territories with varying restrictions and conditions for use . of the human body . Even then , within individual states , such as in Colorado , 0003 ) The brainstem serves as the vital pathway for relay marijuana laws vary greatly from county to county . and processing of neural impulses flowing continuously [0008 ] Although defined under U . S . federal law as having between the brain and the rest of the body . It is about the size no medical use , U . S . Pat. No . 6 ,630 ,507 is held by the of the thumb and contains the most dense and complicated United States Department of Health and Human Services, wiring systems in the human body . In addition to the axons covering use of cannabinoids for treating a wide range of and dendrites (wires ) that carry nerve impulses , the brain diseases. It is directed to a method of treating diseases stem also contains critical nuclei that function as electrical caused by oxidative stress comprising administering a thera generators and relays. Some of the nuclei are related to peutically effective amount of a cannabinoid ( e . g ., canna cranial nerve function while others serve as generators and bidiol) that has substantially no binding to the NMDA impulse centers for pain perception , the autonomic system receptor to a subject who has a disease caused by oxidative “ fight or flight” response , wakefulness and alertness , as well stress . as cardio - respiratory and related autonomic functions . [0009 ] Previously , the assignee has filed for patent pro 10004 ] The endocannabinoid system ( ECS ) is involved in tection for its inventions related to topical regional neuro regulating a variety of physiological processes including affective therapy ( “ TRNA THERAPY " ) with cannabinoids, appetite , pain and pleasure sensation , immune system , such as cannabidiol (CBD ) . This is accomplished via admin mood , and memory . Endocannabinoid receptors in the brain istration of effective amounts of these agents on the back of interact with cannabinoids from different sources, including the neck . That technology is covered , e . g ., by U . S . patent ( endocannabinoids ( brain derived , e . g . , from foods (Omega application Ser . No. 15 /058 , 946 , filed Mar. 2 , 2016 ( entitled 3s and Omega -6s ); phytocannabinoids (plant derived , e . g . , “ Topical Regional Neuro - Affective Therapy with Cannabi from buds , tinctures, extracts , including tetrahydrocannabi noids” ) and U . S . patent application Ser . No. 15 /228 ,690 filed nol ( THC ) , cannabidiol (CBD ) , cannabinol (CBN ) , etc .) ; Aug . 4 , 2016 ( entitled “ Topical Regional Neuro -Affective and synthetic cannabinoids ( such as tetrahydrocannabinol Therapy with Cannabinoid Combination Products ” ) , by of ( THC ) ) . Cannabinoids are a diverse class of chemical com which are hereby encompassed by reference . pounds that act on cannabinoid receptors on cells and [ 0010 ] Caryophyllene acts on same cannabinoid receptors influence neurotransmitter release in brain . These receptor as “medical marijuana ” and CBD , medical component of proteins include endocannabinoids produced naturally in cannabis . Unlike cannabis or marijuana , caryophyllene is humans and animals , phytocannabinoids in cannabis and unregulated and completely legal in all states. some other plants , and chemically manufactured synthetic cannabinoids. Phytocannabinoid 9 - tetrahydrocannabinol ( THC ) is the primary psychoactive compound of cannabis . SUMMARY OF THE INVENTION Cannabidiol (CBD ) is another major constituent of the plant, 10011 ] It is an object of the invention to provide a topical and comprises up to 40 % extracts of plant resin . At least 85 formulation which includes one or more agents which act on different cannabinoids isolated from cannabis exhibit varied same cannabinoid receptors as “ medical marijuana ” and effects . CBD ( the medical component of cannabis ) , but which [ 0005 ] The medical value of cannabis or marijuana has ( unlike cannabis or marijuana ) is unregulated and com been recognized for thousands of years . In the United States , pletely legal in the United States . 1800 ' s to 1930 ' s , medical cannabis was widely marketed [0012 ] It is an object of the present invention to provide a and used , promoted by traditional drug companies . In 1890 , method of treatment in humans with topical afferent neural Parke - Davis and Eli -Lilly joint- ventured to breed Cannabis activation therapy via the regional administration of one or Americana in Greenfield , Ind . Despite benefit in treating more caryophyllene ( s ) useful for the treatment of such diverse conditions, potential of cannabis for psychoactive diseases or conditions that may be treated via such therapy . US 2018 / 0049994 A1 Feb . 22 , 2018 [0013 ] It is an object of the present invention to provide a [0019 ] In certain preferred embodiments , the method fur method for the treatment of seizures ; encephalopathy ther comprises applying a sufficient amount of the topical including lethargy , focus /attentional problems, and cogni pharmaceutical formulation to the back of the neck region of tive issues: spasticity ; weakness ; pain , including radiculopa the human patient such that the onset of a therapeutic effect thy and neuropathy ; numbness ; anxiety and other mood occurs in less than about 30 minutes, or in less than 15 disorders ; hypertension ; Parkinson ' s disease ; insomnia ; as minutes . The topical pharmaceutical formulation may be well as any other disease or condition that may be treated administered ( applied to the back of the neck region ) on a with a cannabinoid . once a day basis , or on a twice a day basis , a three times a [0014 ] It is an object of the present invention to provide a day basis , or on a four times a day basis . method for the treatment of seizures ; epilepsy ; encephalopa [ 0020 ] In certain embodiments , the patient is treated for a