Here is what we are waiting on.BRIGHT Phase 2,and also FDA meeting date anounced on DEES.Could happen any day now.
Then the big one... FX phase 3 results sometime in June,and FDA NDA...meeting.
DEVON, Pa., March 7, 2019 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that it has initiated the Phase 2 BRIGHT (An Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Autism Spectrum Disorder) trial. The trial will assess the safety, tolerability and efficacy of Zygel (previously referred to as ZYN002) for the treatment of child and adolescent patients with Autism Spectrum Disorder (ASD). The Company expects to present topline data from this study in the first half of 2020.
“Autism spectrum disorder can have a devastating impact on a child and their family,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “The medical need is significant and unmet despite high awareness and advocacy efforts. Though there has been an accelerating rate of diagnosis, to date there are only two FDA approved products indicated for the treatment of ASD symptoms. Both have significant side effect profiles, and neither have been approved to address the key symptoms of social impairment and anxiety. We are excited to initiate the BRIGHT trial evaluating the role of Zygel in ASD and are hopeful that Zygel may improve some of the core social and behavioral symptoms of ASD. We look forward to presenting topline data in the first half of 2020.”
The 14-week BRIGHT trial is an open-label multi-dose Phase 2 clinical trial designed to evaluate the efficacy and safety of Zygel in approximately 36 children and adolescents (ages four through 17) with ASD as confirmed by DSM-5 diagnostic criteria for ASD. Enrolled patients will receive weight-based initial doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist, Parent Rated Anxiety Scale – Autism Spectrum Disorder, Autism Impact Measure, and Clinical Global Impression – Severity and Improvement.
