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.
Mood Disorders
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.
USPSTF Finds Evidence Lacking for Vitamin D Screening
Current evidence inadequate to determine benefits and harms of screening for vitamin D deficiency
Telepsychology Use Up 12-Fold in the US During Pandemic
However, adoption of telepsychology has varied according to individual and practice characteristics
Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
MPR Weekly Dose Podcast Episode 46
This week there’s more COVID vaccine developments; A first-of-its-kind trial assessing a drug for preventing COVID in long term care facilities; A cannabidiol treatment gains another indication; Depression treatment gains indication for major depressive disorders with acute suicidal ideation or behavior; And the FDA requests more information for their review of the peanut allergy treatment, Viaskin.
Spravato Approved for MDD With Acute Suicidal Ideation or Behavior
The approval was based on the ASPIRE I and II trials that compared the efficacy and safety of esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, to placebo in 449 adults with moderate to severe MDD who had active suicidal ideation and intent.
Vitamin D3 Does Not Reduce Depression Incidence, Recurrence
Incidence and recurrence of depression, change in mood scores did not differ from placebo for adults ≥50.
Botox Injections May Ease Depression
An FDA database revealed that people who receive Botox injections report less depression.
