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(12) Patent Application Publication (10) Pub. No.: US 2016/0256411 A1 AUNG-DIN (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2016/0256411 A1 AUNG-DIN (43) Pub US 2016O256411A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0256411 A1 AUNG-DIN (43) Pub. Date: Sep. 8, 2016 (54) TOPICAL REGIONAL NEURO-AFFECTIVE Publication Classification THERAPY WITH CANNABINOIDS (51) Int. Cl. (71) Applicant: Afgin Pharma, LLC, Sarasota, FL (US) A63L/05 (2006.01) A 6LX 9/27 (2006.01) (72) Inventor: Ronald AUNG-DIN, Sarasota, FL (US) A619/00 (2006.01) (52) U.S. Cl. CPC ............... A61 K3I/05 (2013.01); A61 K9/0014 (73) Assignee: Afgin Pharma, LLC, Sarasota, FL (US) (2013.01); A61 K9/127 (2013.01) (57) ABSTRACT (21) Appl. No.: 15/058,946 A method of treating a disease state or condition in humans via topical brainstem afferent stimulation therapy via the administration of a cannabinoid drug(s) to the back of the (22) Filed: Mar. 2, 2016 neck of a human patient to provide R neuro-affective therapy is disclosed. In certain preferred embodiments, the Related U.S. Application Data cannabinoid drug(s) are not psychoactive or Substantially not psychoactive. In certain embodiments, the cannabinoid drug (60) Provisional application No. 62/299,260, filed on Feb. (s) are incorporated into a pharmaceutically acceptable topi 24, 2016, provisional application No. 62/126,757, cal carrier, e.g., a cream. In certain preferred embodiments, filed on Mar. 2, 2015. the cannabinoid drug(s) comprises cannabidiol. Patent Application Publication Sep. 8, 2016 Sheet 1 of 11 US 2016/0256411 A1 FGURE retationship of upper cervice nerves at the sack of neck, a resisti gas Merxes are ryyyyyyyyyyyyyyyyyyyyyyyyyyyyyyy XXXXXXXXXXXXXXXXXXXXXXXXXX Patent Application Publication Sep. 8, 2016 Sheet 2 of 11 US 2016/0256411 A1 FIGURE 2 Patent Application Publication Sep. 8, 2016 Sheet 3 of 11 US 2016/0256411 A1 FIGURE 3 Patent Application Publication Sep. 8, 2016 Sheet 4 of 11 US 2016/0256411 A1 GURE 4 2 Patent Application Publication Sep. 8, 2016 Sheet 5 of 11 US 2016/0256411 A1 FIGURES Patent Application Publication Sep. 8, 2016 Sheet 6 of 11 US 2016/0256411 A1 FIGURE 6 38' x: 8:3 Patent Application Publication Sep. 8, 2016 Sheet 7 of 11 US 2016/0256411A1 FI GURE 7 Patent Application Publication Sep. 8, 2016 Sheet 8 of 11 US 2016/0256411 A1 FIGURE 8 Patent Application Publication Sep. 8, 2016 Sheet 9 of 11 US 2016/0256411 A1 FIGURE 9 i. froxxerx seigure fests w FIGURE 10 atterated seizure facias Patent Application Publication Sep. 8, 2016 Sheet 10 of 11 US 2016/0256411 A1 FIGURE 11 case § §*** § IGURE 12 after Patent Application Publication Sep. 8, 2016 Sheet 11 of 11 US 2016/0256411 A1 FIGURE 13 US 2016/0256411 A1 Sep. 8, 2016 TOPCAL REGIONAL NEURO-AFFECTIVE While benefits for treating symptoms of diverse neurologic THERAPY WITH CANNABINOIDS and psychiatric conditions have been known and practiced by ancient civilizations for thousands of years, marijuana's psy 0001. This application claims priority to U.S. Application choactive effects have also led to abuse and labeling as a No. 62/126,757, filed on Mar. 2, 2015 and U.S. Application "gateway drug for more addictive compounds. There is no No. 62/299,260, filed on Feb. 24, 2016; the disclosures of class of therapeutic compounds with more controversy and which are hereby incorporated by reference herein. Stigma than cannabinoids, active components of the cannabis FIELD OF THE INVENTION plant. 0007. The U.S. Government has indicated there is no 0002 The invention relates to topical regional neuro-af medical benefit for marijuana and classified it Controlled fective therapy (“TRNA THERAPY) with cannabinoids, Substance Category 1, as heroin. It is considered by federal such as cannabidiol (CBD). This is accomplished via admin law, illegal to possess or use cannabis and its associated istration of effective amounts of these agents on the back of products. However, increasing number of states have chal the neck. lenged this position and legalized cannabis within their ter ritories with varying restrictions and conditions for use. Even BACKGROUND OF THE INVENTION then, within individual states, such as in Colorado, marijuana 0003. The approximate 2/2 pound human brain is com laws vary greatly from county to county. prised of the most complex material known to man. The 0008 Although defined under U.S. federal law as having neuron, the primary functional cell of the nervous system, no medical use, U.S. Pat. No. 6,630,507 is held by the United operates on the basis of electrical impulses that result in the States Department of Health and Human Services, covering release of neurochemical Substances (neurotransmitters) at use of cannabinoids for treating a wide range of diseases. It is specific receptors: dopamine, serotonin, acetylcholine, nore directed to a method of treating diseases caused by oxidative pinephrine, gamma-aminobutyric acid (GABA), and many stress comprising administering a therapeutically effective others. There are estimated to be 80-100 billion (10 times the amount of a cannabinoid (e.g., cannabidiol) that has substan world population) neurons in the average human brain. These tially no binding to the NMDA receptor to a subject who has neurons, in turn, make 200-300 billion coded connections a disease caused by oxidative stress. with other neurons to accomplish the complex tasks of the human body. SUMMARY OF THE INVENTION 0004. The brainstem serves as the vital pathway for relay and processing of neural impulses flowing continuously 0009. It is an object of the present invention to provide a between the brain and the rest of the body. It is about the size method of treatment in humans with topical afferent neural of the thumb and contains the most dense and complicated activation therapy via the regional administration of one or wiring systems in the human body. In addition to the axons more cannabinoids useful for the treatment of Such diseases and dendrites (wires) that carry nerve impulses, the brainstem or conditions that may be treated via Such therapy. also contains critical nuclei that function as electrical genera 0010. It is an object of the present invention to provide a tors and relays. Some of the nuclei are related to cranial nerve method for the treatment of seizures; encephalopathy, includ function while others serve as generators and impulse centers ing lethargy, focus/attentional problems, and cognitive for pain perception, the autonomic system “fight or flight' issues: spasticity; weakness; pain, including radiculopathy response, wakefulness and alertness, as well as cardio-respi and neuropathy, numbness; anxiety and other mood disor ratory and related autonomic functions. ders; hypertension; Parkinson's disease; insomnia; as well as 0005. The endocannabinoid system (ECS) is involved in any other disease or condition that may be treated with a regulating a variety of physiological processes including cannabinoid. appetite, pain and pleasure sensation, immune system, mood, and memory. Endocannabinoid receptors in the brain interact 0011. It is an object of the present invention to provide a with cannabinoids from different sources, including (en method for the treatment of seizures; epilepsy; encephalopa docannabinoids (brain derived, e.g., from foods (Omega-3s thy, including lethargy, focus/attentional problems, and cog and Omega-6s); phytocannabinoids (plant derived, e.g., from nitive issues; spasticity; weakness (e.g., muscle weakness); buds, tinctures, extracts, including tetrahydrocannabinol pain, including radiculopathy and neuropathy, lower back (THC), cannabidiol (CBD), cannabinol (CBN), etc.); and pain, and fibromyalgia; numbness and/or tingling; anxiety synthetic cannabinoids (such as tetrahydrocannabinol and other mood disorders; hypertension and autonomic dys (THC)). Cannabinoids are a diverse class of chemical com function; Parkinson's disease and tremors; insomnia; Bell's pounds that act on cannabinoid receptors on cells and influ palsy and facial nerve dysfunction; glaucoma, AIDS; cancer, ence neurotransmitter release in brain. These receptor pro PTSD; trigeminal neuralgia; hemi-facial spasms; Autism/AS teins include endocannabinoids produced naturally in perger's; attention Deficit Disorder and Hyperactivity; social humans and animals, phytocannabinoids in cannabis and isolation; occipital neuralgia; TMJ dysfunction related Symp Some other plants, and chemically manufactured synthetic toms; cognitive problems including memory disturbance; cannabinoids. Phytocannabinoid A9-tetrahydrocannabinol headaches (migraine and tension); peripheral neuropathy; as (THC) is the primary psychoactive compound of cannabis. well as other conditions or disease states mentioned herein or Cannabidiol (CBD) is another major constituent of the plant, any other disease or condition that may be treated with a and comprises up to 40% extracts of plant resin. At least 85 cannabinoid. different cannabinoids isolated from cannabis exhibit varied 0012. The above objects and others are attained by virtue effects. of the present invention, which is directed in part to a method 0006. There is no greater example of a “double-edged of treating a disease state or condition in a human patient via Sword in medical therapeutics than medical marijuana. topical regional neuro-affective (TRNA) or regional neuro US 2016/0256411 A1 Sep. 8, 2016 affective (RNA) therapy via administration of a drug at the tremor related to MS, a drug for the treatment of chronic back of the neck region, or the back of the neck. e.g., at the encepahalopathies, a drug for the treatment of congenital hairline (BONATH). CNS degeneration conditions/cerebral palsy, a drug
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