Zynerba Pharmaceuticals Announces Publication of Data from Phase 3 CONNECT-FX Study of Zygel™ in the Journal of Neurodevelopmental Disorders
Study finds patients with Fragile X who have a highly methylated FMR1 gene that were treated with Zygel showed a significant reduction in behavioral symptoms compared to those treated with placebo
Topline results from follow-on RECONNECT confirmatory pivotal Phase 3 trial of Zygel in patients with a completely methylated FMR1 gene expected in second half 2023
Excerpt from the Press Release:
Devon, PA, November 28, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced that the results from the Phase 3 CONNECT-FX study of Zygel for the treatment of behavioral symptoms in children and adolescents with Fragile X syndrome (FXS) were published in the Journal of Neurodevelopmental Disorders.
The paper titled, “A Randomized, Controlled Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (CONNECT-FX),” details how Zygel was well tolerated in patients with FXS and demonstrated efficacy with a favorable benefit risk profile in patients with ≥90% methylation of the FMR1 gene, in whom gene silencing is most likely, and the impact of FXS is typically most severe. The article can be accessed online at the Journal of Neurodevelopmental Disorders at https://rdcu.be/c0sKz.
“Children with Fragile X syndrome are dramatically impacted by debilitating behavioral and emotional challenges, including anxiety, social avoidance, irritability, inattention and aggression,” said Elizabeth Berry-Kravis, M.D., Ph.D., Professor, Department of Pediatrics and Neurological Sciences, Rush University Medical Center.
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