DEVON, PA — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, presented a poster recently at SLEEP 2021, the 35th Annual Meeting of the Associated Professional Sleep Societies, LLC. A copy of the poster is available on the Zynerba corporate website at http://zynerba.com/publications/.
The poster titled “Impact of ZYN002 Cannabidiol Transdermal Gel on Sleep in Children and Adolescents with Developmental and Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder,” shows that in an open-label Phase 2 trial with patients with developmental and epileptic encephalopathies (DEE), treatment with Zygel™ was associated with improved sleep in children with clinically significant sleep disorders at baseline. Furthermore, the children with both DEE and autism spectrum disorder (ASD) showed more wide-ranging benefits on sleep compared to those with DEE alone.
“Epilepsy and sleep disorders have a bidirectional relationship and co-occur in individuals with ASD. Improvements in sleep may result in better seizure control and behavior in these medically fragile children with DEE,” said Joseph M. Palumbo, M.D., LFAPA, MACPsych, Chief Medical Officer of Zynerba. “While these results are exploratory in nature, they are encouraging and warrant confirmation in future clinical trials of Zygel in patients with DEE and/or ASD.”
In the open-label Phase 2 trial with Zygel in patients with DEEs aged 3 to ≤17 years, improvements were observed in different aspects of sleep in the two groups. In patients with ASD (n=5), improvements compared to baseline were observed over the 26-week study period in sleep breathing (p=0.018), sleep wake transition (p=0.006) and the total sleep disturbance scale for children (p=0.024). In patients without ASD (n=11), improvement was seen in initiating and maintaining sleep (p=0.033). Zygel was well tolerated in the trial. Most treatment-emergent adverse events were characterized as mild or moderate. Over the 26-week study period, 60.4% participants had ≥1 related adverse event, with 93% mild/moderate severity.
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