NEW ORLEANS — Treatment with ZYN002, an investigational transdermal cannabidiol (CBD) gel, was well-tolerated and consistently effective for adults with focal epilepsy, according to study data presented at the 72nd Annual Meeting of the American Epilepsy Society, held November 30-December 4, 2018.
Recently studied CBD products in children with refractory epilepsy have administered via the oral route. ZYN002, however, is the first permeation-enhanced pharmaceutical transdermal CBD gel developed.
The phase 2A, randomized, double-blind, placebo-controlled STAR 1 (Synthetic Transdermal CAnnabidiol for the TReatment of Epilepsy; N=174) study evaluated the efficacy and safety of ZYN002 195mg, ZYN002 390 mg or placebo in adults (ages 18 to 70 years) with focal seizures.
Patients who completed the 12-week study were able to continue into the 24-month open-label extension STAR 2 study (N=171). In STAR 2, patients were converted from their blinded dose to open-label 390 mg daily; they were allowed to increase their dose