ZYN002 Cannabidiol Transdermal Gel for Autism & Fragile X - Stephen O'Quinn, PHARMD @Synchrony2021

ZYN002 is a pharmaceutically produced cannabidiol transdermal gel in development for the treatment of behavioral symptoms associated with autism spectrum disorder (ASD) and Fragile X Syndrome (FXS). FXS is the most common monogenic cause of ASD. The results of recently completed trials evaluating the safety and efficacy of ZYN002 in ASD and FXS will be discussed. The design of a new Phase 3 trial in FXS, RECONNECT, will also be reviewed.

Data suggest that ZYN002 is well tolerated in children and adolescents age 3 through 17 years. The most common treatment-related adverse event in patients receiving ZYN002 has been application site pain; occurring in less than 7% of patients and generally mild in severity. There have been no reports of significant laboratory changes, including liver function. Open-label efficacy data in ASD suggest ZYN002 may improve behavioral symptoms of ASD, including irritability, social withdrawal and anxiety, as well as some core symptoms of ASD. Controlled clinical trials in ASD are warranted to confirm these effects.

Data also demonstrate short-term and longer-term improvements in social avoidance in FXS in patients with complete or near complete methylation of the FMR1 gene. The RECONNECT trial is planned to confirm results in patients with FXS.

Stephen O’Quinn, PharmD is a senior pharmaceutical executive with over 30 years of experience in clinical development, medical affairs and commercialization of medicines in multiple therapy areas, including neurology and psychiatry.

Prior to joining Zynerba, Dr. O’Quinn spent over 20 years with GlaxoSmithKline in senior leadership roles. Following his time at GlaxoSmithKline, he spent 5 years as a consultant to pharmaceutical clients supporting clinical development and medical affairs activities. Dr. O’Quinn earned a Doctor of Pharmacy from the University of North Carolina at Chapel Hill. He completed a post-doctoral fellowship in Cardiovascular Pharmacotherapy with the UNC School of Pharmacy and Division of Cardiology.

#cannabidiol #cannabinoid #medicalcannabis #cbd

🎥 This talk was part of Synchrony 2021 Online Symposium - 'From Bench to Biopharma', organised by the The BRAIN Foundation in partnership with UC Davis MIND Institute and CalTech.

🎥 For more Synchrony 2021 talks and highlights:
   • Synchrony Symposium 2021 - From Bench...  


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Synchrony https://synchronysymposium.com/ is the first and only international symposium on translational research in #autism, that brings together academia, #biotech, pharmaceutical companies and #venture partners from around the world with the mission to improve health and quality of life of people with #autismspectrumdisorder.

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The BRAIN Foundation https://brainfoundation.org/ is a 501c(3) non-profit. The founders of BRAIN envision a world where every child and adult on the autism spectrum is healthy, participates fully in education and employment, and has a better quality of life. It aims to catalyze research that results in evidence-based interventions for the disabilities associated with autism, and also results in better medical standard of care.

To accomplish this, it funds impactful research through #philanthropy and our network of partners in the venture, corporate, and grassroots community.