Zynerba Pharmaceuticals Announces Dosing of First Patients in Phase 2 STAR 1 Clinical Study of ZYN002 CBD Gel in Adult Epilepsy Patients with Refractory Focal Seizures

DEVON, Pa., Aug. 01, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the first patients have been dosed in the Company’s Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial, a randomized, multi-center, multi-dose study to evaluate ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures.  ZYN002 CBD gel is the first and only synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery and is in development for the treatment of epilepsy, osteoarthritis (OA) and Fragile X syndrome (FXS).

The STAR 1 clinical trial will evaluate ZYN002 CBD gel in 180 refractory epilepsy patients. The study includes an 8-week baseline period to assess seizure frequency and type.  As patients complete the baseline period, they will be randomized 1:1:1 to receive (i)195 mg of ZYN002 4.2% CBD gel every 12 hours, (ii) 97.5 mg of ZYN002 4.2% CBD gel every 12 hours or (iii) placebo gel every 12 hours for 12 weeks. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period.  Safety and tolerability will also be evaluated.  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.

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