Additional Administration Option Approved for Nuplazid Capsules
Nuplazid is approved for the treatment of hallucinations and delusions associated with Parkinson disease psychosis.
Psychosis
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.
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.
Mortality Risk Up With Newer Antipsychotic Use for Depression
Risk up for nonelderly adults with augmentation with newer antipsychotic versus second antidepressant.
MPR Weekly Dose Podcast Episode 52
This week we cover new Moderna vaccine results; Boxed Warning for benzodiazepines; Point-of-care COVID-19 antibody test; Diphenhydramine overdoses linked to TikTok ‘challenge’; And FDA grants Nucala new approval. Also we look at this week’s developments in drugs in the pipeline.
Antihypertensive Meds and Depression Risk Examined
Depression rates down with nine antihypertensive agents, including enalapril, amlodipine, atenolol
Pimavanserin sNDA Under Review for Dementia-Related Psychosis
The FDA has accepted for filing the supplemental New Drug Application (sNDA) for pimavanserin (Nuplazid®; Acadia) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
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.
