Sanofi is second in the number of Clinical Trials Registered with the FDA

Cannabis and the Pharmaceutical Industry

Drug products containing a synthetic form of THC (dronabinol) have been approved by the U.S. FDA (FDA) for decades (Table 1). Epidiolex, a seizure treatment approved in 2018, was the first Cannabis-derived CBD drug to be approved in the U.S.

Table 1:  Cannabinoid Drugs Approved by the FDA

Drug Product Year Approved API Indication(s)
Marinol 1985 Dronabinol Cancer – prevent nausea, vomiting, inappetence
Sativex 2010 (UK) 1:1 Ratio THC:CBD Multiple sclerosis – pain
Nabiximols(Sativex) FDA approval pending C. sativa L. extract Schizophrenia and neurological conditions
Syndros 2017 Dronabinol Anorexia – AID syndromeCancer – nausea and vomiting
Epidiolex 2018 CBD Lennox-Gastaut syndrome/Dravet syndrome – seizures

There are other indications of the pharmaceutical industry’s growing interest in developing Cannabis-based products, including the agreement between Tilray (a Canadian Cannabis company) and Sandoz, a subsidiary of Novartis. The objective of this partnership is for existing and future medical marijuana products to be sold in any of the 35 countries where medical marijuana is legal. Another start-up pharmaceutical company, Pure Green Pharmaceuticals, Inc., patented a soluble sublingual tablet containing CBD and THC that can be rapidly absorbed into the circulatory system (comparable to smoking Cannabis). The tablets are undergoing clinical trials to determine their effectiveness in treating osteoarthritis and other musculoskeletal pain. The company has another tablet containing CBD and THC that is in clinical trials for menstrual pain relief.

According to data compiled and provided by Cannabis Business Executive, there were 16 pharmaceutical companies conducting cannabinoid clinical trials as of June 2018. Figure 2 shows the number of clinical trials for each company.

Figure 2: Companies with Clinical Trials Registered with the FDA

The market availability of THC overall is widespread and ever-growing. However, due to manufacturing inefficiencies and poor-quality control/oversight, many products do not meet their label claim for THC content. The pharmaceutical arena is poised to offer THC products with consistent quality that builds consumer confidence. With strict, GMP manufacturing standards already in place, pharmaceutical companies and contract development and manufacturing organizations (CDMOs) can produce higher quality products than their consumer counterparts. Clinical studies to determine the efficacy of THC for several conditions provide an opportunity for pharmaceutical companies to add another portfolio of treatments to their current pipelines.

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