FDA Rejects Schizophrenia Tx; ADHD & Mental Health; Eating Disorder Treatment Scarce

The FDA hit Teva Pharmaceuticals and MedinCell with a complete response letter in regard to their new drug application for the schizophrenia treatment TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use). Underpinned by two phase III studies — the RISE and SHINE studies — the developers said they plan to work with the FDA to address concerns.

People with severe mental illnesses, like schizophrenia and bipolar disorder, were found to have a higher risk of cardiovascular disease-related mortality versus the general population, according to a systematic review and meta-analysis. (PLOS Medicine)

A new national survey found that 42% of adults with ADHD were considered to be in excellent mental health. “This research marks a paradigm shift. Most previous research, including my own, has focused on mental illness among those with ADHD so to focus on those who are thriving mentally is refreshing and very heartening,” said study author Esme Fuller-Thomson, PhD, of the University of Toronto, in a statement. (International Journal of Applied Positive Psychology)

Eating disorder treatment options are few and far between in rural areas, which became particularly apparent during the COVID-19 pandemic when rates doubled among teenage girls. (Kaiser Health News)

An analysis of papers published in neuroscience and psychiatry journals from 2009 to 2019 found a 30% increase in the number of studies that included both sexes. However, only 19% of articles from 2019 were shown to have an “optimal design” to distinguish possible sex differences. (Nature Communications)

The owner of a Florida addiction treatment facility was convicted after unlawfully billing health insurance companies more than $58 million for services that were either never rendered or not medically necessary. (Department of Justice)

A preclinical animal study of the investigational PTSD treatment NYX-783 — a novel NMDA receptor-positive allosteric modulator — showed reductions in fear and return of fear, Aptinyx announced. The agent is currently being studied in a phase IIb study in humans.

The online ADHD treatment provider Ahead is shuttering its virtual doors, saying it will only provide care to current patients through June 24. (Bloomberg)