Cannabidiol is a non-psychoactive cannabinoid. Naturally occurring cannabinoids are found in cannabis plants.
ZYN002 is the first synthetic CBD formulated as a patent-protected permeation-enhanced gel. It is delivered transdermally, or across the skin, which means it has the potential to reduce the adverse effects associated with oral dosing.
The Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) trial was initiated in June 2016 to evaluate ZYN002 CBD gel in adult epilepsy patients with refractory focal seizures.
The double-blind, multicenter trial screened 224 patients with refractory epilepsy. The primary endpoint, or yardstick, of the trial was the median percentage change in seizure frequency during the twelve-week treatment period.
Zynerba expects to exceed its target of randomizing 180 patients once additional patients complete the eight-week baseline period. The screening failure rate has been 10 to 15 percent.
Results of Zynerba’s Phase 1 ascending dose study of ZYN002 were released in June 2016. They showed that the CBD gel was well-tolerated and safe at all doses in thetreatment groups.
The twice-daily dose also demonstrated a favorable pharmacokinetic profile, or ability for the body to absorb and use the drug. That profile was similar between the groups. The only adverse events were some gastrointestinal complaints, which occurred at a similar rate in the groups.
The results of the Phase 1 trials will be used to determine the proper doses for evaluating ZYN002 in the Phase 2 trial of adults with refractory epilepsy (STAR 1).
The Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) trial was initiated in August 2016 to evaluate ZYN002 CBD gel in patients with osteoarthritis.
“Reaching our target patient enrollment in the STAR 1 and STOP Phase 2 clinical studies represents key clinical milestones for Zynerba, and we remain on-track to report top-line data for each trial in July/August of this year,” Armando Anido, chairman and chief executive officer of Zynerba, said in a press release. “The rapid enrollment and significant interest in our trials is highly encouraging. We will continue working diligently to move these potential treatments through clinical and regulatory development as efficiently as possible.”