Zynerba Pharmaceuticals (NASDAQ:ZYNE) announced the initiation of a Phase 1 clinical trial for its ZYN002 cannabidiol (CBD) gel for the treatment of refractory epilepsy, fragile X syndrome and osteoarthritis.
As quoted in the press release:
The “Single Rising Dose Study in Normal Subjects and Patients with Epilepsy” study will evaluate the pharmacokinetic profile and tolerability of ZYN002 in 32 healthy volunteers and then in 12 patients with epilepsy. The first group of healthy volunteers was dosed today in Australia. Results are expected in the first half of 2016.
About ZYN002 CBD gel:
Zynerba’s ZYN002 CBD Gel is the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel and is being studied in refractory epilepsy, Fragile X syndrome and osteoarthritis. ZYN002 is a clear, odorless, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with convenient once- or twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC, as demonstrated in a Zynerba in vitro study, which may lead to increased psychoactive effects.
Armando Anido, chairman and CEO of Zynerba, commented:
The initiation of the ZYN002 CBD Gel Phase 1 trial is an important development milestone for Zynerba. We believe our novel, highly innovative and proprietary transdermal gel may offer unique advantages by delivering drug through the skin and into the bloodstream. Transdermal delivery of CBD not only avoids first-pass metabolism but it also avoids potential degradation of CBD into THC in the stomach and the associated increased psychoactive effects of THC. ZYN002 CBD gel presents significant promise for large unmet patient populations.