Zynerba Pharmaceuticals Announces Positive Top Line Results from ZYN002 CBD Gel Phase 1 Multiple Rising Dose Trial and Initiation of Phase 2 Study in Adult Epilepsy Patients with Refractory Focal Seizures

Two additional Phase 2 clinical trials are expected to begin in 2H16 in patients with Osteoarthritis and Fragile X Syndrome

DEVON, Pa., June 27, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced positive top line results from a Phase 1 multiple rising dose clinical trial of ZYN002 cannabidiol (CBD) gel in development for the treatment of epilepsy, osteoarthritis and Fragile X Syndrome (FXS). The Phase 1 study was a randomized, double-blind, placebo-controlled trial to evaluate the pharmacokinetic (PK) profile and tolerability of several dose levels of ZYN002 (200, 250 and 500 mg) in 24 healthy volunteers and 12 patients with epilepsy. The healthy volunteers and patients were dosed for seven days with either ZYN002 CBD gel or placebo gel.

Top line results from the 24 healthy volunteers ranging from 25 to 53 years old and 12 epilepsy patients from 19 to 65 years old demonstrated that ZYN002 CBD gel was safe and well-tolerated at all dose levels. The PK findings are being used to establish the high and low doses for the Phase 2 studies. The twice daily dosing provided a more favorable PK profile with comparable results between healthy volunteers and epilepsy patients.

Transdermal application of ZYN002 was very well tolerated with minimal skin erythema. Skin dryness at the application site was common for both ZYN002 and placebo gel. Overall, the incidence of adverse events associated with ZYN002 CBD gel was similar to placebo in both healthy volunteers and adult epilepsy patients. There were no reports of somnolence or fatigue and a very low incidence of gastrointestinal events was observed. There were no serious adverse events or discontinuations for healthy volunteers and epilepsy patients receiving ZYN002 CBD gel. One healthy volunteer receiving placebo gel developed a serious adverse event suspected to be a catheter infection and was discontinued from the study.

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