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Chemically made cannabis products are on the rise as the medical community acknowledge the medical benefits but many lawmakers still will not budge. One example of this phenomenon is Zynerba, and their THC and CBD products.
Who are Zynerba?
Zynerba Pharmaceuticals developed and commercialized ZYN001. The drug was formulated as a patent up through 2031. ZYN001 is a synthetic THC patch. The other product Zynerba makes is made with synthetic CBD, ZYN002 CBD gel. ZYN002 is for different neuropsychiatric disorders than ZYN001, including Fragile X Syndrome, Adult Refractory Epilepsy, and Developmental Epileptic Encephalopathies.
Whether ZYN002 or ZYN001, we are seeing an expansion in the market for medical cannabis mimic drugs for severe ailments. Zynerba claims they are dedicated to developing next-generation, skin applied cannabinoid medicines for rare and severe neuropsychiatric disorders in patients who are not currently receiving adequate relief.
What is ZYN001?
ZYN001 is a pro-drug of THC (Tetrahydrocannabinol) patch. THC is one of the over one hundred cannabinoids found in the cannabis plant. It is in Phase 1 of clinical programs still. The medical synthetic cannabis patch is being developed for patients with neuropsychiatric disorders, particularly Tourette Syndrome.
Pro-drugs are administered in an inactive or less active form and designed to enable more practical delivery and then are converted into an active form through a normal metabolic process.
ZYN001 is distinct in that it is absorbed through the skin directly. Drugs administered orally have limitations in efficacy and health, involving low bioavailability (i.e. the level of the drug that reaches circulation when introduced to the human body. The state of the art skin patch also avoids “significant first-pass liver metabolism.”
First-pass liver metabolism means the process with which the liver breaks down medicine ingested using the gastrointestinal system through oral delivery methods. This allows only a small amount of the drug to be absorbed into the circulatory system rather than the mass potential. Oral THC has to dose multiple times a day. Due to how the drug is administered, the potency is lost once it goes through the liver’s metabolic system.
In contrast, transdermal therapeutics are designed to be directly absorbed through the skin, avoiding first-pass liver metabolism, thus, allowing for a lower dose to assure efficacy. ZYN001 will offer once-a-day dosing, as an easily applied patch.
As ZYN001 is synthetic and not taken from a cannabis plant, Zynerba will have an easier time with production, given the natural resources and security measures currently required to grow cannabis. The drug is instead pharmaceutically manufactured in a CGMP (Current Good Manufacturing Practice) facility that complies with FDA and CGMP federal regulations.
What is ZYN001 For?
ZYN001 largely treats Tourette Syndrome. Tourette Syndrome (TS) is classified as a neurodevelopmental disorder with the common symptoms of motor and vocal tics. The disorder is noticeable in early childhood. It impacts around 140,000 children and adolescents in the United States alone. Of these children and adolescents, 86% suffer from other mental, developmental, or behavioral conditions.
According to The National Institute of Neurological Disorders and Stroke, 200,000 Americans suffer from the most severe form of TS. In the general public, as many as one in every 100 exhibit milder and less complex symptoms, such less-severe chronic vocal or motor tics.