Zynerba Pharmaceuticals (ZYNE +7.6%) initiates a Phase 2 clinical trial, STOP, assessing lead product candidate ZYN002 for the treatment of knee pain due to osteoarthritis, an affliction affecting 31M Americans.
STOP is a double-blind placebo-controlled study that will enroll up to 300 patients. After a baseline phase, subjects will be randomized to receive either 125 mg or 250 mg of ZYN002 4.2% cannabidiol (CBD) gel every 12 hours or placebo gel every 12 hours for 12 weeks. The primary endpoint is the change from baseline in the weekly mean of the 24-hour average worst pain score. Top-line data are expected in H1 2017.
ZYN002 is formulated as a permeation-enhanced gel for the transdermal delivery of synthetic cannabidiol. It is also under development for the treatment of Fragile X syndrome.