GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)'s cannabidiol drug Epidiolex is inching closer to another FDA approval.
What Happened
GW Pharma reported Monday after the close with positive topline results from a Phase 3 study of Epidiolex in the treatment of seizures associated with tuberculosis sclerosis complex, or TSC.
TSC is a rare genetic condition that causes tumors in different body organs, most often in the brain, skin, heart, eyes, kidneys and lungs, causing a variety of health problems. The symptoms usually appear before a child is six months old.
In the trial, Epidiolex met the primary endpoint of reduction in seizures, with both the 25 mg/kg/day and 50 mg/kg/day dose groups showing similar results of achieving seizure reductions of 48.6 percent and 47.5 percent from the baseline, respectively, compared to 26.5 percent for placebo.
All key secondary endpoints also supported the effects of the primary endpoint, and the safety profile was consistent with the findings from the previous studies, according to GW Pharma.
Why It's Important
Epidiolex, the first prescription, plant-derived cannabinoid medicine in the U.S. — highly purified CBD — secured its first approval in June 2018 for treating two rare and severe form of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 and older.
TSC affects about 40,000 to 80,000 individuals in the U.S. and about 1 million to 2 million people worldwide. About 90 percent of the patients with TSC will develop epilepsy, which becomes intractable to medication, GW Pharma said.
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The company said the results represent the fifth consecutive positive Phase 3 trial for Epidiolex.
Separately, GW Pharma reported first-quarter results, showing Epidiolex sales of $33.5 million, accounting for about 86 percent of its product sales.
What's Next
GW Pharma said it intends to submit an sNDA to the FDA in the fourth quarter of this year and expects approval in 2020.
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