ZygelTM (ZYN002 Cannabidiol Gel)

Zygel is the first and only pharmaceutically-manufactured cannabidiol, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is being developed for patients affected by Fragile X syndrome (FXS) and 22q11.2 deletion syndrome (22q).

Zygel is an investigational treatment. This means that it is not approved for commercial distribution by government regulatory bodies, including the U.S. Food and Drug Administration (FDA).

Addressing Limitations of Current Treatments

Challenge: Oral administration

Oral administration can lead to limitations in safety and efficacy including gastrointestinal side effects like nausea, vomiting and diarrhea, low bioavailability, inconsistent plasma levels and significant first-pass liver metabolism. First-pass liver metabolism refers to the process by which the liver breaks down drugs ingested directly or indirectly through the gastrointestinal system, such as through oral or oral-mucosal delivery methods, allowing only a small amount of drug to be absorbed into the circulatory system.

Potential Benefit of Zygel:
Zygel is a unique permeation-enhanced cannabidiol transdermal gel. Transdermal therapeutics are applied topically and absorbed through the skin directly into the systemic circulation, resulting in a lower incidence of gastrointestinal side effects, and avoidance of first-pass liver metabolism, which potentially enables lower dosage levels of active pharmaceutical ingredients and rapid, reliable absorption with increased bioavailability. Other potential benefits of transdermal delivery compared with oral administration may include fewer drug-drug interactions.

Challenge: Topical Administration

Cannabidiol and other cannabinoids are complex molecules that do not penetrate the skin efficiently without the use of technologies that improve their penetration. As such, topical formulations of cannabidiol Including oils derived from cannabis may require very high doses to reach therapeutic blood levels, or may not cross the skin and into the bloodstream at all.

Potential Benefit of Zygel:
Zygel is a proprietary pharmaceutically-manufactured cannabidiol gel formulated with permeation enhancers, which improve the ability of cannabidiol to cross through the skin and into the bloodstream when administered directly to the skin (transdermal delivery).

Challenge: Cannabidiol degradation to THC in the stomach

An in vitro (performed in a lab in a test tube, culture dish, or elsewhere outside of a living organism) study, titled “Identification of Psychoactive Degradants of Cannabidiol in Simulated Gastric and Physiological Fluid,” which was conducted by Zynerba and published in April 2016, demonstrated that cannabidiol is degraded to THC in an acidic environment such as the stomach. THC is the principal psychoactive cannabinoid. As such, we believe that degradation of cannabidiol into THC in the gastrointestinal tract may lead to increased negative psychoactive effects.

Potential Benefit of Zygel:
Transdermal delivery of Zygel avoids the gastrointestinal tract and potential degradation to THC in stomach acid, which should minimize the risk of negative psychoactive effects.

Challenge: Botanically derived cannabinoids

Botanical derived cannabinoids may face significant challenges for a number of reasons including incongruent and varying federal and state laws, lack of Good Manufacturing Practices (GMP) and regulatory oversight leading to inconsistent batch to batch production and risks, as noted in published literature, regarding contaminants in the soil and products, such as heavy metals.

Potential Benefit of Zygel:
Zygel is pharmaceutically-manufactured in a cGMP facility that complies with rigorous safety standards established by global regulatory agencies and is not extracted from the cannabis plant. We believe that producing cannabidiol this way ensures that we can provide consistent potency and efficiently scale manufacturing to meet the needs of the markets that we are targeting, without the cost and logistical requirements of growing and harvesting cannabis.

Zygel: Permeation-Enhanced Gel

Zygel is a pharmaceutically-manufactured cannabidiol formulated as a permeation-enhanced gel for transdermal delivery.

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