Zynerba Pharmaceuticals (NASDAQ:ZYNE) Inc said it presented a poster on the long-term safety and efficacy of its cannabidiol transdermal gel, Zygel, at the 2022 Society of Biological Psychiatry (SOBP) Annual Meeting held in New Orleans, Louisiana, and virtually, from April 28-30, 2022.
The poster, titled 'Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (FXS) (ZYN2-CL-017)', showed Zygel was well-tolerated in long-term administration of up to 38 months of exposure in an ongoing safety and efficacy study of the drug in children and adolescents with FXS.
Zygel is in development for the potential treatment of behavioral symptoms associated with FXS, autism spectrum disorder (ASD), and 22q11.2 deletion syndrome (22q), noted the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders.
“The efficacy data were evaluated through 15 months of treatment demonstrating meaningful improvement in social avoidance, with the greatest improvement being seen in patients with complete methylation of their FMR1 gene,” the company said.
READ: Zynerba Pharmaceuticals says Zygel has received orphan drug designation in Europe
Zynerba said Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally.
"The data from our long-term open-label study in patients with Fragile X syndrome continue to demonstrate that Zygel has the potential to meaningfully improve the behavioral symptoms of the most impacted individuals in this vulnerable population of children and adolescents," said Armando Anido, chairman and CEO of Zynerba, in a statement.
Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions, the company noted.
Zynerba has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.
"We are committed to bringing this promising therapy to patients and their families within the Fragile X community," Anido added.
Contact the author at jon.hopkins@proactiveinvestors.com