Cannabidiol Drug for Epilepsy Expected Later This Year
A cannabidiol therapy—the first in a new category of antiepileptic drugs—is expected to launch in the second half of this year, after its manufacturer’s New Drug Application was accepted by FDA.
Epidiolex, manufactured by GW Pharmaceuticals, demonstrated a reduced monthly drop in seizure frequency compared to placebo in highly-treatment-resistant patients with Lennox-Gastaut syndrome (LGS), a rare form of epilepsy, according to a study published in The Lancet. Over a 14-week treatment period, 44% of patients taking Epidiolex saw a significant reduction in seizures, compared with 22% of the placebo group.
"LGS is one of the most difficult types of epilepsy to treat, and the majority of patients do not have an adequate response to existing therapies," said Elizabeth Thiele, MD, PhD, a professor of Neurology at Harvard Medical School, and lead author of the Lancet study. "These results show that Epidiolex may provide clinically meaningful benefits for patients with LGS."
FDA accepted the NDA for Epidiolex to treat LGS and Draven syndrome, another rare childhood-onset epilepsy, in December.