Zynerba Pharmaceuticals Announces Phase 3 RECONNECT Trial Design for Zygel™ in Fragile X Syndrome
Zynerba Pharmaceuticals, Inc. (ZYNE)
Last zynerba pharmaceuticals, inc. earnings: 3/10 06:50 am
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Source: GlobeNewswire
- Confirmatory pivotal trial expected to be initiated in the third quarter of 2021 - - Zynerba to hold conference call today, May 5, 2021 at 5:30 pm ET - DEVON, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a confirmatory Phase 3 trial of Zygel in patients with Fragile X syndrome (FXS). The trial, which will be called RECONNECT (A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome), is designed to evaluate the efficacy and safety of Zygel in children and adolescents with FXS. The study is planned to confirm the positive results observed in a population of responders in the Compa
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