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Zynerba cannabis-derived gel for Fragile X syndrome succeeds in phase 2 trial

PBR Staff Writer Published 29 September 2017

Zynerba Pharmaceuticals reported that its cannabis-derived gel to treat Fragile X syndrome (FXS) dubbed as ZYN002 has yielded positive results in a phase 2 trial.

The Pennsylvania-based specialty pharmaceutical company said that the phase 2 study FAB-C had met its primary endpoint by recording an improvement by 46% at week twelve in the total score of Anxiety, Depression, and Mood Scale (ADAMS) compared to baseline.

ZYN002 cannabidiol (CBD) gel was evaluated in 21 pediatric and adolescent patients with Fragile X for duration of 12 weeks. It was applied to the enrolled patients who were also given other medications.

The cannabis-derived gel was also found to have registered clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), stated Zynerba. ABC-FXS addresses some of the main symptoms of Fragile X syndrome which include social avoidance, temper tantrums, hyperactivity and repetitive movements.

Zynerba stated that results of multiple secondary endpoints of the FAB-C trial further supported the results recorded in the ADAMS.

ZYN002 turned out to be very well tolerated with its safety profile in line with the findings of its previous studies.

Zynerba chairman and CEO Armando Anido said: “The clinically meaningful improvements in Fragile X symptoms and the excellent tolerability seen in the FAB-C trial are compelling.

“These data will allow us to discuss the pathway to approval in a meeting with the FDA, which we expect to take place during the first half of 2018.”

Considered to be a difficult genetic autism spectrum disorder to handle, Fragile X shows complex symptoms in patients that significantly affects them and also their families. Currently, there are no approved therapeutic options for Fragile X.