Back to regular programming this week with a summary of the top news, which includes updated travel guidance; Six month efficacy data for the Moderna and Pfizer-BioNTech vaccines; Vial doses increased for Moderna; A new ADHD drug is approved; And the FDA has issued a safety communication regarding lamotrigine.
The approval was based on data from an extensive development program that included four phase 3 studies involving more than 1000 patients 6 to 17 years of age with ADHD.
Azstarys consists of serdexmethylphenidate, a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate.
The review included a total of 81 unique trials that reported 1 or more outcomes of interest.
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.
