Zynerba Pharmaceuticals, Inc. announced that it has initiated the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) exploratory Phase 2 clinical trial of ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery. Fragile X syndrome (FXS) is an autism spectrum disorder and the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections and results in a spectrum of intellectual disabilities, social anxiety and memory problems. In the US, there are about 71,000 patients suffering with FXS. The FAB-C Trial is an exploratory clinical trial designed to evaluate the safety and efficacy of ZYN002 CBD gel in approximately 16 patients between the ages of 8-17 years with Fragile X syndrome. Dosing will be initiated at 50 mg of CBD in ZYN002 4.2% gel once daily and may be titrated up to 125 mg two times per day during the six-week titration period. Between weeks six to twelve, patients will receive a maintenance dose of 50 mg, 100 mg or 250 mg daily of CBD in ZYN002 4.2% gel.