The FDA has cleared EndeavorRxTM (AKL-T01; Akili Interactive) for use as a prescription-only video game-based digital therapeutic to improve attention function in pediatric patients aged 8-12 years with primarily inattentive or combined-type ADHD.
Centanafadine is a serotonin-norepinephrine-dopamine reuptake inhibitor. The two, 6-week, multicenter, double-blind, placebo-controlled trials (Study 1 and Study 2) evaluated the efficacy and safety of centanafadine sustained-release tablets in approximately 900 adult patients with ADHD.
AR19 is an investigational immediate-release, amphetamine formulated to prevent the manipulation of the pellets in the capsules for nonmedical use.
n August 2018, the Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) stating the application required additional data to further assess the efficacy and tolerability of dasotraline.
The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
Treatment should include evidence-based approaches and account for coexisting conditions.
The New Drug Application (NDA) for viloxazine hydrochloride (SPN-812; Supernus Pharmaceuticals), a serotonin norepinephrine modulating agent, has been submitted to the Food and Drug Administration (FDA) for the treatment of pediatric patients with attention deficit hyperactivity disorder (ADHD). The submission is supported by data from an extensive development program that included four phase 3 studies…
There appears to be an increased risk of cardiac symptoms, but not cardiac arrhythmias, in patients using stimulants and quinolone antibiotics concomitantly compared with those taking stimulants plus amoxicillin or azithromycin, according to the findings of a recently published retrospective cohort study. In the study, MarketScan claims data (between 2008 and 2015) of privately-insured patients…
Cord biomarkers of in utero acetaminophen exposure tied to increased risk for childhood ADHD, ASD.
Recommendations include screening for comorbid conditions, understanding ADHD is chronic condition
