The gel is designed to be transmitted through patches on the skin and as well as epilepsy is being targeted at osteoarthritis (OA) and Fragile X syndrome (FXS).
Some 180 refractory epilepsy sufferers will be treated in the trial. After an 8-week baseline period the patients will split into three with two receiving different doses of ZYN002 and one a placebo.
The study is being conducted at 14 sites in Australia and New Zealand. Top line results are expected to be reported in the first half of 2017.
Armando Anido, Zynerba’s chief executive, said: “We are pleased by the pace of the clinical program for ZYN002 and remain on track to initiate additional Phase 2 studies in OA and FXS in the second half of this year.
“We expect to report top line results from all three studies in the first half of 2017.”
Transdermal therapeutics are absorbed through the skin directly into the systemic circulation
Approximately 2.2mln patients in the US and more in Europe and Japan are afflicted with epilepsy with focal seizures representing 35% of all epilepsy incidents.