LOS ANGELES -- Transdermal cannabidiol gel (ZYN002) reduced seizures in focal epilepsy and was well tolerated, according to results of the STAR 1 and STAR 2 trials.
STAR 1 was a double-blind, placebo-controlled trial that assessed ZYN002 at 195 mg and 390 mg doses in 188 patients. After 12 weeks of treatment, however, there weren't any significant reductions in focal seizures over placebo, reported John Messenheimer, MD, a consultant for Zynerba Pharmaceuticals, and colleagues.
The 24-month STAR 2 open-label extension trial -- for the 174 patients who completed STAR 1 -- reported a 58% median reduction in seizure rates at month 12. Patients in STAR 2 began at the 390 mg dose and had the option to switch to a dose of 195 mg, 585 mg, or 780 mg. But Messenheimer and colleagues noted that there were too few patients receiving the highest two doses to report on any possible dosage differences.
Although the treatment was generally well tolerated, the most common treatment-emergent adverse events included headaches and viral and bacterial upper respiratory tract infections. One patient in STAR 2 reported increased anxiety, which may be related to the treatment.
Disclosures
Authors of the ZYN002 study received payments from Zynerba Pharmaceuticals and include employees of the company.
Primary Source
American Academy of Neurology
Messenheimer J, et al "Transdermal cannabidiol (CBD) gel for the treatment of focal epilepsy in adults" AAN 2018; Abstract P4.468.