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 is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.
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…
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 approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
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.
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
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.
Psychosis and BPD have previously been linked to persistent nightmares in childhood, and these findings highlight the importance of confronting sleep disturbances at young ages.
For psychiatric professionals, Administrations of Lunacy offers a critical exploration of psychiatry’s historic links to key moments in American history by focusing on an asylum that was the largest in the world in the mid-20th century.
