Dexmedetomidine Oral Thin Film NDA Submitted for FDA Review
The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I and II studies.
Schizophrenia
FDA Issues Complete Response Letter for Olanzapine/Samidorphan
While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
Application for Long-Acting Schizophrenia Treatment Submitted
PP6M is a long-acting injectable antipsychotic designed to reduce the number of injections patients with schizophrenia receive.
MPR Weekly Dose Podcast Episode 54
This week: News of another vaccine trial being put on hold; A trial assessing hyperimmue globulin beings; An NDA for IV tramadol is rejected; FDA Committees vote on novel schizophrenia and bipolar I disorder therapy; And a first approval for Ebola.
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.
Sublingual Dexmedetomidine Promising for Acute Agitation With Schizophrenia, Bipolar Disorder
Dexmedetomidine is currently available as a solution for intravenous infusion for use in clinical anesthesia and sedation in an intensive care setting.
Phase 3 Trial Evaluating Roluperidone in Schizophrenia Misses End Points
Minerva Neurosciences announced that its phase 3 trial of roluperidone (MIN-101) did not meet the primary and key secondary end points for the treatment of negative symptoms in schizophrenia.
Novel Agent Promising for the Treatment of Schizophrenia
Reduction in PANSS total score greater for non-D2-receptor-binding drug SEP-363856 versus placebo.
Secuado Transdermal System Now Available for Schizophrenia
The approval was supported by data from a 6-week, phase 3, double-blind, placebo-controlled, fixed-dose study that compared the efficacy and safety of Secuado 3.8mg/24 hours and 7.6mg/24 hours to placebo in 616 adult patients with schizophrenia.
FDA Approves Caplyta for Schizophrenia
The Food and Drug Administration (FDA) has approved Caplyta (lumateperone; Intra-Cellular Therapies), an atypical antipsychotic, for the treatment of schizophrenia in adult patients. The approval was based on results from 2 double-blind, placebo-controlled trials (Study 1 [N=335] and Study 2 [N=450]) that evaluated the efficacy of Caplyta in patients with schizophrenia for 28 days. Findings…
