Medical Marijuana and the Pharmaceutical Industry

By guest blogger Preeti Parikh – Head of Business Development at RAS LifeScience Solutions, a boutique pharma/life sciences consulting firm.

The history of medical marijuana…

Cannabis’ (Marijuana) use as a medicine dates back to 4000 BC in China. During the 19th century and till early 20th century, marijuana was used globally to treat various illnesses such as migraine, neuropathic pain, musculoskeletal pain and in childbirth.2

In Canada, cannabis was added to the Confidential Restricted List in 1923 under the Narcotics Drug Act Amendment Bill.3

Cannabis was listed under Schedule 1 drugs and made illegal in the United Kingdom in 1928 but doctors could prescribe it until the Misuse of Drugs Act came into play in 1971.

By 1961, the United Nations Single Convention on Narcotics Drugs made a coordinated global effort to prohibit and monitor the use of illicit drugs.6

In the U.S., cannabis was listed for the first time in the United States Pharmacopoeia in 1850. With the passing of the Marihuana Tax Act in 1937, cannabis use was restricted and was ultimately dropped in 1942. Further to this, the Controlled Substances Act in 1970 imposed a complete federal prohibition and listed cannabis as a Schedule 1 controlled substance.3

Despite US federal legislation, New Mexico became the first state to legislatively recognise the therapeutic benefits of cannabis in 1978 and by 1982 there were varying medical cannabis frameworks in place within thirty states. In 1996, California became the first state to legalise the use of botanical cannabis for medicinal purposes under physician supervision with the enactment of the Compassionate Use Act.2

The story now…….

The legal landscape of medical marijuana has evolved dramatically over the last decade.

In the U.S., the medical use of marijuana has now been legalised in 33 states. Fourteen other states have laws that limit tetrahydrocannabinol (THC) content, while allowing access to cannabidiol (CBD) rich products, given it is a non-psychoactive effect. The recreational use of marijuana has been legalised in 11 states (Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington), the District of Columbia, the Northern Mariana Islands, and Guam. Another 15 states and the U.S. Virgin Islands have decriminalised cannabis use.5

Clinical research on the possible uses of cannabinoids for medical treatment is steadily increasing. However, since cannabis is listed as a Schedule 1 controlled substance in the United States, conducting research and raising funds for cannabis-related research is not easy for pharmaceutical companies. Research conducted on cannabis requires licensing from the DEA (specific to Schedule I drugs) as well as approval from the FDA.15

Prior to 2015, research also required approval from the U.S. Public Health Service, but this requirement has now been eliminated to make it less difficult for cannabis research to be approved.

Back in Europe the European Union now allows its EU member states to make cannabis available for pharmaceutical purposes. Doctors may prescribe cannabis for relief of symptoms arising from multiple sclerosis, AIDS, cancer, long-term neurogenic pain, Tourette syndrome, Crohn’s disease, PTSD and other illnesses.3,7

In the U.K., medical cannabis products have been moved from Schedule 1 to Schedule 2 substance in 2018, which allows doctors to prescribe them under certain circumstances.16

In 2018, Canada put in place a federal legislation of cannabis and established co-existing frameworks for recreational and medical use of the plant. Even though the recreational marijuana segment has always been under the limelight since Canadian legalisation, the medical marijuana segment of the cannabis industry has seen some growth over the years: from being commonly prescribed for pain management all the way to new drugs being approved for the treatment of childhood epilepsy.11

Let’s look at the marijuana-based pharmaceutical products approved so far….

Even though cannabis and cannabis-derived products are being used for a number of indications, to-date only three prescription cannabinoids are FDA-approved and legal in the U.S. to be prescribed in all states:10

  • Cesamet (nabilone, a synthetic cannabinoid similar to THC)
    • Originally developed by Eli Lilly and received marketing approval in 1985 but was withdrawn from the market in 1989. It was subsequently acquired by Valeant Pharma in 2004 and received marketing approval for the drug in 2006. Cesamet is prescribed for the treatment of nausea and vomiting associated with chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.13
  • Marinol and Syndros (dronabinol, a synthetic THC)
    • Insys Therapeutics commercially launched Syndros (dronabinol oral solution) in 2017, becoming the first marketed, FDA-approved liquid dronabinol. The agent was FDA-approved in July 2016 for chemotherapy-induced nausea and vomiting in patients who have not responded to conventional antiemetic therapies, and for treating anorexia associated with weight loss in AIDS patients. Syndros is a liquid version of dronabinol, which was originally FDA-approved in 1985 in capsule form, and is marketed by AbbVie under the brand name Marinol.14
  • Epidiolex (plant-derived CBD)
    • Manufactured by GW Pharmaceuticals, Epidolex was approved in 2018 as the first drug to contain a purified extract from the marijuana plant. It is approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.8,12
  • Sativex (a combination of THC and CBD in a 1:1 ratio) is a prescription cannabinoid available in Canada and Europe but not yet U.S. FDA-approved.

The future looks bright…

The legal medical marijuana market is expected to reach $66.3B by the end of 2025, globally. Increasing legalization across the globe and use of marijuana in medical, as well as recreational, applications are some of the drivers for the market growth. Growing adoption of cannabis as a pharmaceutical product to treat various illnesses will boost demand for medical marijuana in the coming years.9,21           

In summary

Despite the regulatory and financial challenges, the medical cannabis industry has witnessed significant achievements over the past year: the FDA approved Epidolex and the global regulatory landscape opened up for the medical cannabis-based pharmaceutical research. The medical marijuana market is poised for growth as more governments across the globe open up regulatory and financial pathways for medical cannabis research and commercialisation.

Glossary

FDA: The Food and Drug Administration

NIDA: The National Institute on Drug Abuse

DEA: The Drug Enforcement Administration

Sources:

  1. The BMJ, August 2018 edition
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5312634/
  3. https://www.healtheuropa.eu/medical-cannabis-sigma/90427/
  4. https://www.aappublications.org/news/2018/06/27/epilepsydrug062718
  5. https://www.esquire.com/lifestyle/a21719186/all-states-that-legalized-weed-in-us/
  6. http://europedecides.eu/2019/04/europe-is-on-the-verge-of-a-cannabis-boom/
  7. https://www.healtheuropa.eu/medical-cannabis-in-europe/92341/
  8. https://www.drugabuse.gov/publications/drugfacts/marijuana-medicine
  9. https://www.grandviewresearch.com/press-release/global-legal-marijuana-market
  10. http://accurateclinic.com/accurate-education-fda-approved-prescription-cannabis-based-medications/
  11. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-cannabis-act-food-and-drugs-act-related-regulations/document.html
  12. https://www.dea.gov/press-releases/2018/09/27/fda-approved-drug-epidiolex-placed-schedule-v-controlled-substance-act
  13. https://www.medscape.com/viewarticle/540937
  14. https://www.drugdevelopment-technology.com/comment/syndros-first-fda-approved-liquid-dronabinol-launched-long-journey/
  15. https://www.workingpartners.com/hurdles-legalizing-marijuana-medicine/
  16. https://www.independent.co.uk/life-style/health-and-families/health-news/medicinal-cannabis-legalised-access-marijuana-nhs-a8903051.html
  17. https://www.investopedia.com/biggest-challenges-for-the-cannabis-industry-in-2019-4583874
  18. https://www.forbes.com/sites/julieweed/2019/02/19/cannabis-executives-reveal-the-industrys-2019-challenges-and-a-few-opportunities-too/#5debec4735ca
  19. https://medium.com/ucsf-magazine/why-is-it-so-hard-to-study-marijuana-d7a17c206fe1
  20. https://www.nap.edu/read/24625/chapter/17#389
  21. https://investingnews.com/innspired/the-future-of-medical-cannabis-cannabinoid-based-pharmaceuticals/
  22. https://www.labelandnarrowweb.com/contents/view_infographics/2018-06-15/cannabis-packaging-opportunities-and-challenges/51904