Zenerba Pharmaceutical is dedicating itself to developing next-generation synthetic cannabinoid treatments through transdermal delivery to address the unmet needs of adult refractory epilepsy patients.
Sector Publishing Intelligence published the announcement made by Zynerba Pharmaceuticals that The STAR 2 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial was initiated as an extension of the STAR 1 clinical trial in which patients received the ZYN002 CBD gel.
The transdermal therapeutic is designed to provide consistent, controlled drug delivery with twice-daily dosing. The CBD gel allows for absorption through the skin in a patch application directly into the systemic circulation. In this way liver metabolism, and possible potential lowering of dosage levels are avoided. The active ingredients are rapidly absorbed in a reliable dose absorption and have high bioavailability.
Transdermal delivery also avoids the gastrointestinal tract, and potential stomach acid degradation of CBD into THC having psychoactive effects as was demonstrated by the in vitro study done by Zynerba.
Patent-protected synthetic CBD
The ZYN002 CBD gel is the first, and only synthetic CBD gel, and is patent-protected, and specifically studied in adult refractory epilepsy patients.
Armando Anido, CEO of Zynerba announced the enrollment of the first patients into the STAR 2 clinical trial, an open-label extension trial which allows patients who have completed the STAR 1 clinical trial to receive treatment with ZYN002 CBD gel for up to 52 weeks.
“Enrollment in STAR 1 is continuing, and we plan to report top line results in the first half of 2017” he said.
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Tolerability and safety of CBD in epilepsy
STAR 2 will provide additional data on tolerability and safety, which Armando Anido believes will establish that the gel is well tolerated in long-term use. It is a multi-center, open-label Phase 2 clinical trial, which will treat epilepsy patients with refractory focal seizures who have completed the STAR 1 study, and will receive 195 mg of CBD in ZYN002 4.2% gel every 12 hours. After two weeks, investigators will be given the option to reduce the dosage to 97.5 mg of CBD in ZYN002 4.2% gel every 12 hours depending on patient response. The trail is conducted at the same 14 sites. The STAR 1 trials were also conducted in Australia and New Zealand.
Zynerba is looking into the development of sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and tetrahydrocannabinol (THC). Transdermal delivery has the potential to reduce reductions in efficacy associated with oral dosing.
Skin patches for pain
In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. A Phase 2 clinical trial in Fragile X syndrome (FXS) will hopefully be initiated by year-end 2016.