Harmony Biosciences' Phase 3 RECONNECT Study Of ZYN002 In Fragile X Syndrome Fails To Meet Goal

(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) announced Wednesday topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS).

The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate.

The RECONNECT Study was a Phase 3 randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of ZYN002, a pharmaceutically manufactured cannabidiol administered as a transdermal gel to patients with FXS ages 3 to under 30 years old.