Brian Park, PharmD

Drug Information Specialist https://www.psychiatryadvisor.com

Brian Park, PharmD, is a Drug Information Specialist at MPR. A graduate of the Ernest Mario School of Pharmacy, Rutgers University, Brian worked as a pharmacy manager at Stop & Shop Pharmacy for 8 years. He is a certified diabetes care pharmacist.

All articles by Brian Park, PharmD

ADHD

FDA to Review Manipulation-Resistant Stimulant Med for ADHD

Brian Park, PharmD

May 27, 2020

AR19 is an investigational immediate-release, amphetamine formulated to prevent the manipulation of the pellets in the capsules for nonmedical use.

Eating Disorders

Dasotraline Development for ADHD, Binge Eating Disorder Halted, NDAs Withdrawn

Brian Park, PharmD

May 21, 2020

n August 2018, the Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) stating the application required additional data to further assess the efficacy and tolerability of dasotraline.

Sleep-Wake Disorders

Clinical Improvement Observed in Narcolepsy Trial Evaluating Once-Nightly Sodium Oxybate Formulation

Brian Park, PharmD

May 8, 2020

Positive topline data from the phase 3 REST-ON trial evaluating FT218 (Avadel), an investigational, once-nightly formulation of sodium oxybate, showed that the treatment led to clinically meaningful improvement in patients with narcolepsy.

Geriatric Psychiatry

Boxed Warning Added to Montelukast Labeling Regarding Neuropsychiatric Events

Brian Park, PharmD

May 7, 2020

Because the benefits of montelukast may not outweigh the potential risk of neuropsychiatric symptoms in patients with allergic rhinitis, use should be reserved for patients who have an inadequate response or intolerance to alternative therapies.

Insomnia Disorder

Daridorexant Improves Sleep, Daytime Performance in Insomnia Study

Brian Park, PharmD

April 30, 2020

Idorsia announced positive topline results from a phase 3 study of daridorexant, an investigational dual orexin receptor antagonist, for the treatment of insomnia.

Schizophrenia and Psychoses

Secuado Transdermal System Now Available for Schizophrenia

Brian Park, PharmD

April 16, 2020

The approval was supported by data from a 6-week, phase 3, double-blind, placebo-controlled, fixed-dose study that compared the efficacy and safety of Secuado 3.8mg/24 hours and 7.6mg/24 hours to placebo in 616 adult patients with schizophrenia.

Schizophrenia and Psychoses

First Generic Injection Version of Geodon Available for Schizophrenia

Brian Park, PharmD

March 26, 2020

Dr. Reddy’s Laboratories announced the launch of Ziprasidone Mesylate for Injection, the generic equivalent of Geodon for Injection (Pfizer).

Alzheimer Disease and Dementia

Belsomra Labeling Updated to Include Data on Insomnia in Alzheimer Disease

Brian Park, PharmD

February 13, 2020

The Food and Drug Administration (FDA) has approved updates to the prescribing information for Belsomra® (suvorexant; Merck) to include study findings for the treatment of insomnia in patients with mild to moderate Alzheimer disease.

Bipolar Disorder

Taro Recalls Lamotrigine After Cross-Contamination With Hypertension Drug

Brian Park, PharmD

January 29, 2020

Taro Pharmaceuticals announced the voluntary recall of 1 lot of lamotrigine 100mg tablets to the consumer level due to cross-contamination with a small amount of enalapril maleate.

Sleep-Wake Disorders

Dayvigo Approved for Insomnia Characterized by Difficulties With Sleep Onset, Maintenance

Brian Park, PharmD

January 8, 2020

The Food and Drug Administration (FDA) has approved Dayvigo (lemborexant; Eisai) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.

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