Zynerba (NASDAQ: ZYNE) is dedicated to improving the lives of people with rare and near rare neuropsychiatric disorders where there is a high unmet medical need by pioneering the development and commercialization of next-generation pharmaceutically-produced cannabinoid therapeutics formulated for transdermal delivery. Cannabinoids interact with specific receptors throughout the body to produce pharmacologic effects, primarily in the CNS and immune systems.
Transdermal delivery has the potential to reduce adverse effects associated with oral dosing because it allows the drug to be absorbed through the skin directly into the bloodstream, avoiding the gastrointestinal tract and lessening the opportunity for GI-related adverse events. It also avoids first-pass liver metabolism, potentially enabling lower dosage levels of active pharmaceutical ingredients with a higher bioavailability and an improved safety profile.
Zynerba’s two lead patent-protected product candidates in clinical development are ZYN002 and ZYN001:
ZYN002 is the first and only pharmaceutically-produced cannabidiol (CBD) formulated as a permeation-enhanced gel for transdermal delivery. Through a proprietary combination of our pharmaceutically-produced CBD and permeation enhancers, we believe we can effectively deliver CBD through the layers of the epidermis and into the circulatory system. The company is currently assessing ZYN002 in Fragile X syndrome and certain adult and pediatric refractory epilepsies.
ZYN001 is a prodrug (a drug administered in an inactive or less active form, designed to enable more effective delivery, and then converted into a different form through a normal metabolic process) of THC that enables transdermal delivery through the skin and circulatory system via a patch, and is currently in Phase 1 clinical development.
Cannabinoids appear to modulate a number of systems, channels and receptors; as such, they may have the potential to be developed in a number of additional important indications, including anxiety, autism spectrum disorder, neuroprotection, cognitive disorders, sleep disturbance, and treatment for certain neuralgias.
Zynerba is a clinical stage company with a compelling wholly-owned clinical pipeline that may address significant unmet medical needs. Currently ZYN002 and ZYN001 are patent protected through 2030 and 2031, respectively, and the Company continually seeks to augment patent protection and explore other opportunities for exclusivity. For example, the US Food and Drug Administration has granted Zynerba Orphan Drug designation for the use of CBD as treatment for Fragile X, which among other incentives, may provide market exclusivity in the approved indication for a period of seven years.