The Unique Challenges Facing Cannabis-based Pharma

By Camille Mojica Rey, Contributing Writer
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In June 2018, the FDA approved the first-ever pharmaceutical derived from the cannabis plant, Epidiolex (cannabidiol, CBD). GW Pharmaceuticals’ lead therapeutic reduces the frequency of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The oral solution is approved for use in patients 2 years of age and older.

In the U.S., marijuana is a Schedule 1 drug, along with heroin and LSD. Three months after its approval, as required by law, Epidiolex was rescheduled to a Schedule 5 drug, the lowest restriction classification, due to its low potential for abuse. The approval was seen as a breakthrough by the leaders of the growing number of pharmaceutical companies working to bring cannabis-derived pharmaceuticals to market. That’s because these companies face a unique tangle of legal, scientific, and societal challenges — and they believe GW is paving the way for them to follow.