Cannabis Investment Report – Overview of FDA‑Approved Cannabinoid Pharmaceuticals (Dec 2017)

KR L PI L AC EL CA TA Cannabis Investment Report | December 2017 Pharmaceuticals Cannabinoid-based pharmaceuticals are drugs containing cannabinoids or cannabinoid-like com- pounds that are either derived from natural cannabis or chemically synthesized. A handful of such drugs have been approved for use to treat certain medical conditions both in the United States and elsewhere. Examples of cannabinoid-based pharmaceuticals that have been approved for use in various countries include Marinol, Syndros, Cesamet and Sativex. Another cannabinoid-based pharmaceuti- cal, Epidiolex, has not yet been approved but could become the first medicine derived from the canna- bis plant to be approved by the U.S. Food and Drug Administration (FDA). The drug Marinol is comprised of dronabinol (a synthetic THC) encapsulated with sesame oil in a soft gelatin capsule. Marinol has been approved by the FDA for use in treating (i) anorexia associated with weight loss in patients with AIDS and (ii) nausea and vomiting associated with cancer chemo- therapy. Marinol is a Schedule HI controlled substance under the U.S. Controlled Substances Act (CSA). Syndros is a drug that contains dronabinol in a liquid solution; it has been approved by the FDA for use by adults in treating the same symptoms for which Marinol has been approved. Syndros is a Schedule II controlled substance under the CSA. Forms of dronabinol have been approved for use in jurisdictions outside the United States, including Canada and Denmark. Cesamet is a drug made up of encapsulated nabilone, a synthetic cannabinoid similar to THC. Cesamet has been approved by the FDA for use in treating nausea and vomiting associated with cancer chemotherapy. Cesamet is a Schedule II controlled substance under the CSA. Forms of nabilone have been approved for use in jurisdictions outside the United States, including Australia, Canada, Mexico and the United Kingdom. Sativex is a mouth spray used for treatment of spasticity caused by multiple sclerosis; it includes THC and CBD derived from cannabis. Sativex was first approved for use in the United Kingdom in 2010, and has been approved for use in at least 30 countries (but not in the United States). Sativex is manufactured by U.K.-based GW Pharmaceuticals and is generally recognized as the first prescription drug in the world to include plant-based cannabinoids. The cannabis extract used in Sativex is a Sched- ule I controlled substance under the CSA. SS ative X 2zmgiasma Solucién para pulverizacion bucal ® pelta-9-tetrahidrocannabinol - - Cannabidiol : , mh 3 envases pulverizadores de 13h | R =) riled ¥ er] Via bucal | b GAlmirall Pharmaceuticals 54 © 2017 Ackrell Capital, LLC | Member FINRA/SIPC HOUSE_OVERSIGHT_024690