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.
Schizophrenia
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.
The Genetic and Heritability Components of Childhood Maltreatment
This genome-wide associated study expanded on the gene-environment correlation for childhood maltreatment and causal relationship between childhood maltreatment and health.
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.
Novel Glycine Transporter Inhibitor Gets Breakthrough Tx Status for Cognitive Impairment With Schizophrenia
The designation is based on results from a phase 2 trial that evaluated the efficacy and safety of 4 different doses of BI 425809 orally once daily in adults with CIAS for 12 weeks.
Dexmedetomidine Oral Film Under Review for Agitation With Schizophrenia, Bipolar Disorder
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
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