Cannabinoid Pharmacology

Cannabinoid

Pharmacology

Understanding Cannabinoid Products and Development Process

Currently there are many types of cannabinoid products and medications available, and it may not be clear how one is different from another.

Products that sound similar may not be equivalent for various reasons, including potential differences in development, manufacturing, testing, and approval.

References: 1. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017. 2. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2013.

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3. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2017. 4. Guidance for industry, Q7 good manufacturing practice guidance for active pharmaceutical ingredients. US Food & Drug Administration website. https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm200364.htm. Accessed October 30, 2017. 5. Small E, Marcus D. Hemp: a new crop with new uses for North America. In: Janick J, Whipkey A, eds. Trends in New Crops and New Uses. Alexandria, VA: ASHS Press; 2002:284-326. 6. Chandra S, Lata H, ElSohly MA, Walker LA, Potter D. Cannabis cultivation: methodological issues for obtaining medical-grade product. Epilepsy Behav. 2017;70:302-312. 7. Mead A. The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law. Epilepsy Behav. 2017;70:288-291.

Potential therapeutic uses for FDA-approved cannabinoid medicines

Institutions have been researching the therapeutic potential of cannabinoids in an effort to develop prescription medicines for FDA approval. Only indications that are being studied in clinical trials are included here.

Theraputic Uses

References: 1. Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med. 2017;376:2011-2020. 2. Varadkar S. Cannabidiol for drop seizures in Lennox-Gastaut syndrome. Lancet. 2018; doi:10.1016/S0140-6736(18)30135-1.

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3. Sativex [package insert]. Berkshire, United Kingdom: GW Pharma Ltd; 2015. 4. Lichtman AH, Lux EA, McQuade R, et al. Results of a double-blind, randomized, placebo-controlled study of nabiximols oromucosal spray as a adjunctive therapy in advanced cancer patients with chronic uncontrolled pain. J Pain Symptom Manage. 2018;55(2):179-188. 5. Fallon MT, Lux EA, McQuade R, et al. Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies. Br J Pain. 2017;11:119-133. 6. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017. 7. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2017. 8. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2013.

Did you know?Did you know there are approved prescription cannabinoid medicines available?
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Did you know there are approved prescription cannabinoid medicines available?

The FDA has approved 3 synthetic cannabinoids and 1 plant-derived cannabinoid. They are indicated to treat:

Tetrahydrocannabinol (THC) and THC analogs (synthetic), Schedule II/III

  • Anorexia associated with weight loss in adult patients with AIDS1,2
  • Nausea and vomiting associated with chemotherapy in adult patients who failed conventional antiemetics1-3

Cannabidiol (plant derived), Schedule V:

  • Seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older

Additionally, a medication that combines 2 types of cannabinoids, THC and CBD, has been studied and approved for use outside the United States.4

Did you know?

There has been a 400% increase in cannabis-related publications in the past 10 years.*