Brian Park, PharmD, Author at Psychiatry Advisor

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.

General Psychiatry

FDA to Review Tasimelteon for Smith-Magenis Syndrome

By

Brian Park, PharmD

August 5, 2020

The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.

Addiction

FDA Requires Labeling Changes for Opioids to Include Information About Naloxone

By

Brian Park, PharmD

July 28, 2020

The FDA has announced that it is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to include new recommendations about naloxone to the prescribing information.

Geriatric Psychiatry

Pimavanserin sNDA Under Review for Dementia-Related Psychosis

By

Brian Park, PharmD

July 24, 2020

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.

An increased risk for the development of psychiatric disorders such as schizophrenia and social anxiety disorder has been found with the use of cannabis; depression to a lesser extent. Individuals who are heavy cannabis users are more likely to report suicidal thoughts than non-users. For patients with bipolar disorder, near-daily cannabis use seemed to increase symptoms of the disorder. However, for patients with schizophrenia or other psychoses, a history of cannabis use has been associated with better performance on learning and memory tasks.

Schizophrenia and Psychoses

Sublingual Dexmedetomidine Promising for Acute Agitation With Schizophrenia, Bipolar Disorder

By

Brian Park, PharmD

July 22, 2020

Dexmedetomidine is currently available as a solution for intravenous infusion for use in clinical anesthesia and sedation in an intensive care setting.

Alzheimer Disease and Dementia

Aducanumab BLA for Alzheimer Disease Submitted for FDA Review

By

Brian Park, PharmD

July 13, 2020

Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).

Insomnia Disorder

Consistent Effects Observed With Daridorexant in Second Insomnia Trial

By

Brian Park, PharmD

July 10, 2020

Positive topline results were announced from the second pivotal phase 3 study evaluating daridorexant (Idorsia), an investigational dual orexin receptor antagonist, for the treatment of insomnia.

Brian Park, PharmD

All articles by Brian Park, PharmD

Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report

Spravato Approved for MDD With Acute Suicidal Ideation or Behavior

FDA to Review Tasimelteon for Smith-Magenis Syndrome

Pimavanserin sNDA Under Review for Dementia-Related Psychosis

Sublingual Dexmedetomidine Promising for Acute Agitation With Schizophrenia, Bipolar Disorder

Aducanumab BLA for Alzheimer Disease Submitted for FDA Review

Consistent Effects Observed With Daridorexant in Second Insomnia Trial

Eszopiclone Highly Effective in Treatment of Insomnia