Phase 2 (FDA Meeting)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Zygel (ZYN002 CBD Gel) for Autism spectrum disorder (ASD) - FDA Meeting
WHAT IS THE NEXT CATALYST EVENT?
FDA Meeting to Discuss Results
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Q4 2020 (see slide 4)
2020: Tolerability and Efficacy of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study [BRIGHT (ZYN2-CL-030)]. Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting.
MECHANISM OF ACTION / RATIONALE
Zygel is the first and only pharmaceutically-produced 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 FXS, ASD in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE) (Learn more HERE).
Updated by HC
ZYNE, Autism spectrum disorder, ASD, Zygel, ZYN002, CBD
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