An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children, Adolescents and Young Adults with Fragile X Syndrome

Fragile X Syndrome (FXS)

Safety assessments will include collection of AEs including seizure assessment if applicable, physical and neurological examinations, 12-lead ECG, safety laboratory assessments (hematology, chemistry, reproductive hormone, prolactin tests, and urinalysis), vital signs, C-SSRS, and findings from the skin irritation checks following treatment.

Change from Baseline (last assessment prior to the first dose of ZYN002) in the ABC-CFXS subscale scores (Social Avoidance, Irritability, Socially Unresponsive/Lethargic, Stereotypy, Inappropriate Speech, and Hyperactivity) at Months 1, 6, 12, 18, 24, 30, 36, 42, and 48/ET., CGI-I at Months 1, 6, 12, 24, 36, and 48/ET., Percent of patients who have ≥25% improvement from Baseline in ABC-CFXS Social Avoidance subscale score at Months 1, 6, 12, 18, 24, 30, 36, 42, and 48/ET., Percent of patients who have ≥25% improvement from Baseline in ABC-CFXS Irritability subscale score at Months 1, 6, 12, 18, 24, 30, 36, 42, and 48/ET., Response rate for patients having both ≥25% improvement from Baseline in ABC-CFXS Social Avoidance subscale score AND improved on CGI-I scale at Months 1, 6, 12, 18, 24, 30, 36, 42, and 48/ET., Response rate for patients having both ≥25% improvement from Baseline in ABC CFXS Irritability subscale score AND improved on CGI-I scale at Months 1, 6, 12, 18, 24, 30, 36, 42, and 48/ET., Percent of patients indicating improvement on the CGI-I (dichotomized) scale at Months 1, 6, 12, 24, 36, and 48/ET., Change from Baseline in CGI-S at Months 1, 6, 12, 24, 36, and 48/ET., Change from Baseline/Day 1 in Caregiver Global Impression of Severity at Months 6, 12, 24, 36, and 48/ET., Caregiver Global Impression of Change at Months 6, 12, 24, 36, and 48/ET., Change from Baseline in PedsQL at Month 6, and Month 12

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