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.
Psychosis
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.
Rexulti Approval Expanded to Include Adolescents With Schizophrenia
The approval was based on data from an ongoing phase 3 trial evaluating the safety and tolerability of brexpiprazole as maintenance treatment of 194 patients aged 13 to 17 years with schizophrenia.
Lybalvi Now Available for Schizophrenia, Bipolar I Disorder
Lybalvi is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.
Invega Hafyera Approved for Twice-Yearly Treatment of Schizophrenia
The Food and Drug Administration has approved Invega Hafyera™ (paliperidone palmitate), an every 6-month injection, for the treatment of schizophrenia in adults. Invega Hafyera is a long-acting atypical antipsychotic that is administered as a gluteal intramuscular injection by a health care professional. Prior to initiating treatment with Invega Hafyera, patients must have been adequately treated…
Important Clozapine REMS Program Changes Announced
According to the FDA, prescribers and pharmacies must be re-certified in the Clozapine REMS program by November 15, 2021 to continue to prescribe or dispense clozapine.
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.
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