Rykindo Approved for Schizophrenia, Bipolar Disorder
The approval was based on data from adequate and well-controlled studies with risperidone long-acting injection (intramuscular).
Diagnosis & Disease Information
Complicated Appendicitis More Likely Among Patients With Psychiatric Disorders
Patients with acute appendicitis between 2000 and 2020 were evaluated for complications on the basis of having a mental health diagnosis.
Aripiprazole 2-Month Under Review for Schizophrenia, Bipolar I Disorder
The NDA is supported by data from a phase 1/2 trial that compared the investigational aripiprazole 2-month, long-acting injectable to aripiprazole 1-month depot.
High-Potency Cannabis Use Associated With Higher Risk for Psychosis
Researchers investigated whether high-potency cannabis may be associated with a higher risk of psychosis and cannabis use disorder compared with lower-potency products.
Xanomeline-Trospium Improves Schizophrenia Symptoms in Phase 3 Trial
The phase 3 EMERGENT-2 trial included 252 patients with schizophrenia who were experiencing symptoms of psychosis.
FDA Panel Votes on Pimavanserin for Alzheimer Disease Psychosis
Although not bound by the committee’s recommendations, the Agency does take them into consideration when making decisions on approval.
Virtual Reality Helps Reduce Agoraphobia Symptoms
Virtual reality has been explored as an adjunct to cognitive behavioral therapy, but little is known about how well it delivers automated therapy. To find out, the researchers conducted a clinical trial using 9 National Health Service trusts in England.
Igalmi Sublingual Film Approved for Agitation With Schizophrenia, Bipolar Disorder
The approval was based on data from the phase 3 SERENITY I and II studies that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively.
Psychosis Risk Influenced by Early-Life Infection, Inflammation, and Metabolic Alterations
Three-quarters of all psychiatric disorders occur by early adulthood (mid-20s). This fact suggests that bio-psychosocial factors occurring from the fetal period through early adulthood could play a crucial role in risk. This nonsystematic review sought to synthesize key epidemiological evidence of relevant risk factors.
FDA Sets Date for Decision on Pimavanserin for Alzheimer Disease Psychosis
Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.
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