ZYN002 – CBD Gel 

First and Only Pharmaceutically-Produced CBD Formulated as a Permeation-Enhanced Gel Being Developed for neuropsychiatric disorders including Fragile X Syndrome, Adult Refractory Focal Epilepsy and Developmental and Epileptic Encephalopathies (DEE).

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 potential benefits of transdermal delivery compared with oral administration may include fewer drug-drug interactions, and lower 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 negative psychoactive effects.

Potential Benefit of ZYN002:
Transdermal delivery of ZYN002 avoids the gastrointestinal tract and potential stomach acid degradation to THC, which should the risk of negative psychoactive effects.

Challenge: Botanically derived cannabinoids
Botanical cannabinoids may 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:
ZYN002 is pharmaceutically manufactured in a CGMP (Current Good Manufacturing Practice) facility that will comply with rigorous efficacy and safety standards established by global regulatory agencies, and is not extracted from the Cannabis plant. We believe that producing CBD this way ensures that we can provide consistent potency and efficiently scale manufacturing to meet the needs of the large markets that we are targeting.


ZYN002: Permeation-Enhanced Gel

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


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


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


Developmental and Epileptic Encephalopathies (DEE)

Developmental and Epileptic Encephalopathies (DEE) are a category of rare and ultra-rare severe brain disorders that manifest with seizures or EEG abnormalities that can directly worsen cognition or behavior. These disorders are often progressive, and are highly resistant to treatment. Examples of DEEs include early myoclonic encephalopathy, epileptic encephalopathy with continuous spike and wave during sleep, and certain syndromes including Ohtahara, West, Landau-Kleffner, Lennox-Gastaut, Doose and Dravet. Treatment of seizures or EEG abnormalities is expected to improve the cognitive or behavioral deficits and reduce the seizures.

DEE patient resources