The Epilepsy Foundation characterizes seizure as a chronic disorder that has recurrent and unprovoked seizures, that affects roughly three million people in the U.S alone, and 150,000 new cases reported each year. There are different forms of epilepsy, and this, along with other factors, such as other health issues and medications, and well as convenience, helps to determine the best treatment option for the sufferer. Substantial evidence suggests that cannabis could play a significant role as an alternative treatment for epilepsy. Cannabidiol (CBD) oil has shown great potential in treating Dravet Syndrome and Lennox-Gastaut Syndrome, which are both different types of epilepsy conditions. Recently, Zynerba Pharmaceutical announced successful trials of its one of a kind synthetic CBD gel, ZYN002, in the treatment of epilepsy.
Zynerba Pharmaceuticals is a clinical-stage specialty pharmaceutical company, with a special interest in synthetic cannabinoid therapeutics formulated for transdermal delivery. Successful development of a viable that utilizes transdermal technologies, could allow sustained, consistent, and controlled delivery of therapeutic levels of cannabinoids such as CBD, which has the potential to minimize adverse effects often associated with oral administration of dosages.
CBD Gel, ZYN002
ZYN002 is the first and only synthetic cannabidiol (CBD) product formulated as a patent-protected permeation-enhanced gel and is designed to provide consistent, controlled and sustained drug delivery with convenient twice-daily dosing. Cannabidiol has been shown to reduce the frequency of seizures in patients with retractable epilepsy. Zynerba has developed ZYN002 for the treatment of refractory epilepsy, osteoarthritis, and Fragile X Syndrome to be administered via transdermal delivery mechanism.
This CBD gel is significant in its function as a transdermal therapeutic. Absorbed through the skin directly into the systemic circulation, transdermal delivery of ZYN002 avoids first-pass liver metabolism (the process by which the liver breaks down therapeutics ingested directly or indirectly through the gastrointestinal system), and potentially enables lower dosage levels of CBD, along with fast and reliable absorption with increased amounts of the active ingredient circulating in your blood that is necessary for active effectiveness. As demonstrated in clinical studies, transdermal delivery of ZYN002 further lower incidences of gastrointestinal events because it avoids the gastrointestinal tract, and this method of delivery also aids in the avoidance of degradation of CBD by stomach acid since it is not applied orally. Its consistent potency, purity, and use of less doses lends to its advantage over other forms of transdermal therapeutics or oral medications.
In clinical studies which assessed ZYN002 gel’s safety, tolerability, and effects on cognition and mood in both healthy adults and adult epilepsy patients with focal seizures, ZYN002 CBD gel was shown to be safe and well-tolerated across a range of concentration and at all dose levels ranging from 50 mg, 100 mg, 125 mg, to 250 mg, in comparison to placebo. Cognitive performance was reported as unimpaired and no changes in psychological health, such as mood, were observed on the Trail Making test. Armando Anido, Chairman and CEO of Zynerba confirmed the results of the Phase 1 study stating, “We did not observe any difference in cognitive performance or mood changes after treatment with ZYN002 CBD gel. Enrollment in our STAR 1 clinical trial in adult epilepsy patients with focal seizures is continuing and we remain on track to report top-line results in the first half of 2017.” , for ZYN002 CBD gel has also launched granting epilepsy patients who participated in STAR 1 the opportunity to receive treatment with ZYN002 CBD gel for up to 52 weeks.
Today, we know that CBD, whether derived from the cannabis plants marijuana or hemp, has shown to have potentially great value in decreasing the frequency of seizures in patients with various epileptic conditions. Zynerba Pharmaceuticals has taken it a step further with its synthetic CBD gel product ZYN002 that is not only created to be quick and effective in its delivery of the active ingredient in the body, but it has been demonstrated to be safe; based on the results of clinical testing, ZYN002 does not interfere with cognitive performance and does not have a negative effect on mood or psychological health on a whole. Testing of ZYN002 is still ongoing, but so far, the results of clinical trials are promising. Further trials need to be conducted to test the effectiveness of ZYN002 in reducing episodes of seizures in particular epileptic conditions.