The first drug that uses the marijuana plant-derived ingredient cannabidiol won approval from the Food and Drug Administration last week.
GW Pharmaceuticals, a British drugmaker, announced June 25 the approval of Epidiolex oral solution for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome – both severe and hard-to-treat forms of epilepsy – in patients aged 2 and older. Epidiolex, the company said, is the first prescription formulation of highly purified, plant-derived cannabidiol, or CBD, which does not produce the high associated with marijuana. The approval was based on the results of three Phase III clinical trials published in The New England Journal of Medicine and the Lancet.
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Other companies developing cannabis-based pharmaceuticals include Kalytera Therapeutics, a Novato, California-based company developing CBD-based drugs for pain, graft versus host disease and others; Zynerba Pharmaceuticals, based in Devon, Pennsylvania, and developing transdermal drugs for neuropsychiatric conditions; and Norwood, Massachusetts-based Corbus Pharmaceuticals, developing the drug lenabasum for inflammatory and fibrotic diseases. Like GW, all four companies are publicly traded, with respective market capitalizations of $23.33 million, $128.83 million and $290 million. However, GW dwarfs all of them, with a $4.22 billion market cap.
Zynerba may be GW’s nearest competitor, given its focus on epilepsy. Last August, the company’s shares sank up to 60 percent when the randomized, double-blind Phase II STAR 1 study of ZYN002 failed to produce a statistically significant reduction in focal seizures compared with placebo. However, data presented in April at the American Academy of Neurology’s annual meeting from the open-label STAR 2 extension showed that longer-term exposure to ZYN002 resulted in greater improvements in seizure frequency among treated patients. The company plans to start a Phase IIb study in adult refractory focal seizures in the second half of this year.
The aforementioned companies are developing pharmaceutical products derived from cannabis, which differs from medical use of marijuana, currently permitted in 30 states and the District of Columbia. In addition, the District of Columbia and eight states – Washington, Oregon, California, Alaska, Nevada, Colorado, Massachusetts and Maine – have legalized marijuana for recreational use, though it remains illegal at the federal level. Nevertheless, the global medical marijuana market is expected to reach $55.8 billion by 2025, according to a report last year by Grand View Research.
Photo: Zerbor, Getty Images
