ZYN002 – CBD Gel 

First and Only Synthetic CBD Formulated as a Permeation-Enhanced Gel Being Developed for Refractory Epilepsy, Osteoarthritis and Fragile X Syndrome

ZYN002 is a synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery. ZYN002 is being developed as a clear gel that is designed to provide consistent, controlled and sustained drug delivery with convenient twice-daily dosing. 

Zynerba ZYN002 CBD Gel Sachet

Addressing Limitations of Current Treatments

Challenge: Oral administration
Oral administration can lead to limitations in safety and efficacy including 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 therapeutics 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 ZYN002:
Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with increased bioavailability. Other benefits of transdermal delivery compared with oral administration may include fewer drug-drug interactions, lower incidence of negative psychoactive effects, lower incidence of gastrointestinal events and the avoidance of degradation of CBD to THC. In clinical studies, ZYN002 has demonstrated no reports of somnolence or fatigue and a very low incidence of gastrointestinal events.

Challenge: CBD degradation to THC in the stomach
An in vitro 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 CBD is degraded to THC in an acidic environment such as the stomach. We believe such degradation may lead to increased psychoactive effects.

Potential Benefit of ZYN002:
Transdermal delivery of ZYN002 avoids the gastrointestinal tract and potential stomach acid degradation.

Challenge: Botanically derived cannabinoids
Botanical cannabinoids create significant challenges for drug manufacturers because of the natural resources and security measures required to grow Cannabis, as well as the strict batch controls required by regulatory agencies in pharmaceutical manufacturing.

Potential Benefit of ZYN002:
Our product candidates are synthetically manufactured per FDA/CGMP regulations. We believe synthetic manufacturing provides consistent potency and eliminates impurities in the product.


ZYN002: Permeation-Enhanced Gel

ZYN002 is a synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery.


Epilepsy

Epilepsy is a disease characterized by an enduring predisposition to generate epileptic seizures (transient symptoms due to abnormal neuronal activity in the brain) and by the neurobiological, cognitive, psychological and social consequences of the condition. The most common seizure type in patients with epilepsy is the focal seizure also known as a partial onset seizure. Focal seizures start in a small area of the brain and quickly involve other areas of the brain and often affect alertness and awareness. Approximately 2.2 million patients in the US battle epilepsy. Focal seizures are the most common type of seizure, representing 35% of all epilepsies.

Epilepsy patient resources


Osteaorthritis

Osteoarthritis is a degenerative joint disease that leads to wear and tear of the joints and affects the cartilage,  joint lining, ligaments and bone. It is the most common form of joint disease and tends to occur most often in the hand joints, spine, hip, knees and great toes. It is characterized by the breakdown of the joint cartilage,  bony changes in the joints and deterioration of the tendons and ligaments leading to pain and inflammation of the joint lining. Approximately 31 million patients in the US battle osteoarthritis.

Osteoarthritis patient resources


Fragile X Syndrome

Fragile X syndrome is a genetic condition that causes intellectual disability, anxiety disorders, behavioral and learning challenges and various physical characteristics. The impairment can range from learning disabilities to more severe cognitive or intellectual disabilities. Patients with Fragile X syndrome exhibit autism-like symptoms including cognitive impairment, anxiety and mood swings, attention deficit and heightened stimuli. Approximately 71,000 patients in the US battle Fragile X syndrome.

Fragile X syndrome patient resources