Zynerba, a Pennsylvania-based pharmaceutical company, is testing the effectiveness of a CBD gel as a treatment for autism. Cannabidiol, or CBD, is a cannabis extract that has been shown to relieve symptoms of chronic pain, anxiety, and ADHD.
According to a report this month by Philly Mag.com, Zynerba recently launched a clinical trial to test its lead product, Zygel, a CBD gel applied through the skin. Zygel is the first and only pharmaceutically manufactured CBD in gel form, and lacks the compound THC, meaning it does not produce the “high” of cannabis or marijuana.
The trial, CONNECT-FX, will evaluate the safety and effectiveness of Zygel in 204 children and adolescents between three and seventeen years old with Fragile X syndrome, a genetic disorder that shares symptoms of autism. Zynerba received orphan drug designation from the FDA in March 2018, indicating Zygel as a safe treatment for individuals with Fragile X syndrome. Zyerba received a second patent for its skin-permeating technology from the U.S. Patent and Trademark Office in June 2019. Armando Anido, Zynerba’s CEO, hopes to submit a new drug application to the FDA by 2020 if the trial results are positive.
Anido believes Zygel is especially important due to the fact that there are currently no therapeutic options approved for the treatment of behavioral symptoms associated with Fragile X syndrome. Many children are reluctant to take oral medications, which often lead to nausea and gastrointestinal side effects. Zygel avoids these problems by being applied through the skin.
“When we looked at what’s available and saw that there was nothing available for Fragile X Syndrome, we knew this was a high unmet need,” Anido said. “That’s why we went into these areas. It gives us a nice opportunity to make a huge difference for these patients who have no other treatment options.”