Leveraging manufacturing technology to CBD
Zynerba utilizes an established pharmaceutical manufacturing process to replicate the structure and function of the CBD found in the Cannabis plant. Lot consistency, reproducibility, purity and supply are required elements of any pharmaceutical manufacturing process. Zynerba believes that its manufacturing process will allow it to reproducibly manufacture its transdermal CBD gel to meet the stringent global regulatory agencies’ standards while ensuring consistent and efficient supply – without the costs and logistical requirements of growing and harvesting Cannabis.
Our commitment to patients drives our research efforts into pharmaceutically manufactured CBD – the same structure and function, without plants.
Our Lead Candidate:
Zygel™ (ZYN002 CBD Gel) is the first and only pharmaceutically-manufactured CBD, 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 suffering from neuropsychiatric conditions including Fragile X syndrome (FXS), Autism Spectrum Disorder (ASD) in pediatric patients, 22q, and certain rare refractory epilepsies called DEEs. The U.S. Food and Drug Administration has granted Orphan Drug designation to Zynerba for the use of CBD for treatment of patients with FXS.
Zygel is an experimental treatment. This means that it is not approved by government regulatory bodies, including the United States Food and Drug Administration (FDA) and other agencies and must be tested to see if it is an effective and safe treatment.