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.
Diagnosis & Disease Information
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.
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.
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.
