Adhansia XR Labeling Updated With Additional Clinical Data
The sNDA approval was based on data from a phase 3 Adult Laboratory Classroom study that assessed the efficacy and safety of Adhansia XR in adults diagnosed with ADHD.
Mood Disorders
Zuranolone Bests Placebo in Postpartum Depression
At day 15, significantly greater reduction seen in depressive symptoms as measured by change in HAMD-17 score from baseline
MPR Weekly Dose Podcast 82
This week the FDA approved a regenerative skin tissue therapy and a treatment for advanced mastocytosis, while Novavax’s vaccine for COVID and a novel treatment for MDD show promise, also the FDA issue warning concering hand sanitizers.
Short-Course Zuranolone Looks Promising for MDD Treatment
Zuranolone is an investigational 2-week, once-daily oral treatment for adults with major depressive disorder.
Links Explored for ADHD Meds, Externalizing Symptoms, Child Suicidality
ADHD medications may moderate the association between externalizing symptoms and risk for suicidality in children
Inhaled Nitrous Oxide Explored for Treatment-Resistant Depression
In phase 2 trial, 25% nitrous oxide comparable to 50% nitrous oxide for reducing symptoms, but with fewer adverse effects
Prenatal Acetaminophen Exposure May Up Risk for ADHD, Autism
However, no link seen between postnatal exposure and later symptoms in childhood
FDA Clears AI-Based Diagnostic Aid for Autism Spectrum Disorder
The approval was based on safety and efficacy data from a study that included 425 patients 18 months through 5 years of age.
Lybalvi Approved for Schizophrenia, Bipolar I Disorder
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
Key Factors ID’d for Bipolar Medication Nonadherence
Patients report side effects, beliefs, and knowledge about bipolar disorder are top reasons for not taking medications
