Posted by Michael Wonder on 07 May 2019
Zynerba Pharmaceuticals receives fast track designation for Zygel for the treatment of behavioural symptoms associated with Fragile X syndrome
6 May 2019 - Enrolment progressing in pivotal CONNECT-FX trial of Zygel in Fragile X syndrome, with data expected in the second half of 2019.
Zynerba Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for the Company’s lead development candidate Zygel (ZYN002 CBD gel) for treatment of behavioural symptoms associated with Fragile X Syndrome (FXS).
Zynerba is conducting a pivotal trial to assess the efficacy and safety of Zygel as treatment for the behavioural symptoms of FXS in pediatric and adolescent patients (three through 17 years of age). Zygel is a pharmaceutically-manufactured CBD formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled transdermal drug delivery into the bloodstream.
