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 lead patent-protected product candidate in clinical development is Zygel™ (formerly known as ZYN002):
Zygel 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 Zygel in Fragile X Syndrome, Autism Spectrum Disorder, a rare genetic neuropsychiatric syndrome called 22q11.2 Deletion Syndrome, and a heterogeneous group of rare and ultra-rare epilepsy syndromes associated with severe cognitive impairment and behavioral disturbances known as developmental and epileptic encephalopathies (DEE).
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 the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions. Zynerba is developing a compelling wholly-owned clinical pipeline that may address significant unmet medical needs. Currently Zygel is patent protected through 2030, 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 Syndrome, which among other incentives, may provide market exclusivity in the approved indication for a period of seven years.