FDA Rejects Pimavanserin sNDA for Dementia-Related Psychosis
The sNDA submission was supported by data from the pivotal phase 3 HARMONY study.
Psychosis
Review Examines Metabolic, Cardiovascular Side Effects of Second-Generation Antipsychotics
A systematic review examined the metabolic and cardiovascular adverse effects in commonly prescribed second-generation antipsychotics.
FDA: Abuse/Misuse of OTC Nasal Decongestant Can Lead to Major Health Complications
Since January 1, 2000, there have been 460 documented cases of propylhexedrine abuse or misuse reported to US poison control centers.
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.
Additional Administration Option Approved for Nuplazid Capsules
Nuplazid is approved for the treatment of hallucinations and delusions associated with Parkinson disease 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.
