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Zygel was generally well tolerated, and the safety profile was consistent with data from previous Zygel clinical trials.

Zynerba Pharmaceuticals Announces Positive Long-Term Data from Phase 2 INSPIRE Trial in 22q11.2 ...

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, presented positive long-term 38-week data from the Phase 2 INSPIRE trial with Zygel in children and adolescents with 22q11.2 deletion syndrome (22q). The data were presented in a poster at the 61st Annual Meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona. A copy of the poster is available on the Zynerba corporate website at www.zynerba.com/publications

By Zynerba Pharmaceuticals, Inc.
Published - Dec 05, 2022, 07:33 AM ET
Last Updated - Apr 04, 2024, 11:00 AM EDT

Zygel™ achieved statistically significant and clinically meaningful improvements from baseline in multiple efficacy assessments and was generally well-tolerated through 38 weeks of treatment

DEVON, Pa., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, presented positive long-term 38-week data from the Phase 2 INSPIRE trial with Zygel in children and adolescents with 22q11.2 deletion syndrome (22q). The data were presented in a poster at the 61st Annual Meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona. A copy of the poster is available on the Zynerba corporate website at www.zynerba.com/publications.

The poster, titled, “ An Open-Label Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE),” shows that through 38-weeks of treatment, statistically significant improvements were seen in children and adolescents treated with Zygel in the Pediatric Anxiety Rating Scale (PARS-R), all five scales of the Anxiety, Depression and Mood Scale (ADAMS), and all five subscales of the Aberrant Behavior Checklist – Community (ABC-C). These results are consistent with the previously reported 14-week treatment data suggesting a positive risk-benefit profile for Zygel in improving anxiety-related and behavioral symptoms in children and adolescents with 22q when added to a stable standard of care.

“The 38-week data from the Phase 2 INSPIRE trial suggest children and adolescents with 22q who received Zygel over a longer term continued to show improvement in anxiety-related and behavioral symptoms,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “These data provide additional support and reinforce our belief in the potential of Zygel for the treatment of anxiety and behavioral symptoms in children and adolescents with 22q.”

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