September 11, 2023
- Harmony Biosciences plans to acquire Zynerba Pharmaceuticals, adding its cannabidiol (CBD) gel product Zygel for Fragile X syndrome and other neuropsychiatric disorders, including autism, to its pipeline. Fragile X is a neuropsychiatric disorder with no FDA-approved therapies and is a leading cause of inherited intellectual disability and autism. In an earlier open-label Phase 2 study, Zygel showed behavioral improvements in adolescents with autism aged 3-17 years, as confirmed by the Aberrant Behavior Checklist-Community (ABC-C) subscale scores, as well as improvements in the Parent-Rated Anxiety Scale-ASD score, the Autism Parenting Stress Index and the Autism Impact Measure relative to baseline.
- A recent study investigated the association between maternal daily consumption of diet sodas or aspartame during pregnancy and the risk of autism in offspring. The study found that boys exposed early to diet sodas or aspartame in utero had an increased risk of autism. However, this association was not observed in girls, who comprised only 17% of autism cases in this study. The lack of association in girls might be due to insufficient sample size or differences in gender response. Further research into this finding is essential, especially considering the widespread use of diet sodas among pregnant women.
- According to a new phase 2 study, treatment with a 25-mg dose of psilocybin, administered with psychological support, led to a significant reduction in depressive symptoms compared to a niacin placebo for adults aged 21 to 65 years. The improvement in depression was apparent within 8 days of psilocybin dosing and was maintained across the 6-week follow-up period. The study also found that psilocybin improved psychosocial functioning and was generally well-tolerated, with most adverse events being mild or moderate. However, psilocybin treatment was associated with a higher rate of overall adverse events and a higher rate of severe adverse events compared to the niacin placebo.
- The Interagency Autism Coordinating Committee (IACC) will hold its next hybrid full committee meeting on Wednesday, October 11, 2023, from 10:00 a.m. to 5:00 p.m. ET in Rockville, MD. This meeting is free and open to the public in person and via NIH Videocast. IACC welcomes public comments, which are due by Wednesday, September 20, 2023, at 5:00 p.m. ET. Go to the meeting page for more information or to submit a public comment.
