Barry Herman

Objectives Evaluate comparative bioavailability of single-dose amphetamine extended-release tablet (AMPH ER TAB, Tris Pharma, Inc., Monmouth Junction, NJ) 20 mg, swallowed whole or chewed and amphetamine extended-release oral suspension (AMPH EROS) 2.5 mg/mL; and evaluate whether a PK food effect exists on AMPH ER TAB (contains a 3.2:1 ratio of d-...

Background In 2016, the US FDA issued an industry guidance document “Quality Attribute Considerations for Chewable Tablets” which describes the quality attributes to be considered when developing chewable tablets. It includes recommendations on selection of acceptance criteria for measuring palatability (having a taste acceptable to the patient or...

Objective Evaluate the relative bioavailability of single-dose amphetamine extended-release tablet (AMPH ER TAB) 20 mg, swallowed whole or chewed, and amphetamine extended-release oral suspension (AMPH EROS) 2.5 mg/mL; evaluate food effect on AMPH ER TAB. Methods Healthy volunteers (18–55 years) were randomized to 1 dose of AMPH ER TAB 20 mg swall...

Purpose: This single-dose pivotal study evaluated the pharmacokinetics of amphetamine extended-release oral suspension (AMPH EROS) under fasted and fed conditions and the relative bioavailability of AMPH EROS and immediate-release mixed amphetamine salts (IR MAS) in adults. Methods: This open-label, randomized, three-period, three-treatment, six-se...

The proprietary, immediate and extended drug delivery technologyLiquiXR® utilizes an ion-exchange resin that complexes with amphetamine or any active moiety that can be protonated and is water-soluble. The active ingredient of the drug product forms a complex with an ion exchange polymer of the resin resulting in micron-sized particles. A portion o...

Objectives: Report the efficacy of open-label amphetamine extended-release oral suspension (AMPH EROS) for the treatment of children with ADHD.AMPH EROS has a 1-hr onset of effect and a duration of action of 13hours and was approved by FDA for treatment of ADHD in children aged 6-17 years based on a double-blind, placebo-controlled efficacy and sa...

OBJECTIVES To determine the efficacy and safety of amphetamine extended-release oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity disorder (ADHD) compared with placebo in a dose-optimized, randomized, double-blind study. METHODS The efficacy of AMPH EROS was evaluated in a laboratory classroom study conducted in 108 p...

Objective To determine whether amphetamine extended-release oralsuspension (AMPH EROS) has an onset of effect at 30minutes postdose inchildren with ADHD. Methods This randomized, double-blind, 2-treatment, 2-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6 to 12 years withattention-deficit/hyperactivity disorder (ADHD) a...

The proprietary immediate and extended drug delivery technology LiquiXR™ utilizes an ion-exchange resin that complexes with amphetamine or any other active moiety that can be protonated and is water-soluble. The active drug product forms a complex with ion-exchange polymers contained in the resin, which is then formed into micron-sized particles. S...

Objective: To determine whether amphetamine extended-release oral suspension (AMPH EROS) has an onset of effect at 30 minutes postdose in children with attention-deficit/hyperactivity disorder (ADHD). Methods: This randomized, double-blind, two-treatment, two-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6–12 years with...

Objective: In two Phase III, randomized, placebo-controlled trials (NCT01718483 and NCT01718509 at ClinicalTrials.gov), lisdexamfetamine dimesylate (LDX) reduced binge eating days/week in adults with moderate-to-severe binge eating disorder (BED). We describe the effects of LDX (50mg and 70mg) on the Sheehan Disability Scale (SDS; exploratory endpo...

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Aim This study compared functioning and productivity in individuals meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐5) diagnostic criteria for binge eating disorder (BED) to those without BED. Methods A sample of US adults from the National Health and Wellness Survey completed an Internet survey in October 2013. I...

Objective: To evaluate physician knowledge of and attitudes about binge-eating disorder (BED) and the value and ease-of-use of the 7-item Binge Eating Disorder Screener (BEDS-7) in clinical practice. Methods: Two internet surveys (wave 1: April 15-May 6, 2015; wave 2: August 19-25, 2015) were administered to primary care physicians serving adult...

Objective: This study examined the time course of efficacy-related endpoints for lisdexamfetamine dimesylate (LDX) versus placebo in adults with protocol-defined moderate to severe binge eating disorder (BED). Methods: In two 12-week, double-blind, placebo-controlled studies, adults meeting DSM-IV-TR BED criteria were randomized 1:1 to receive p...

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Background We linked extensive longitudinal data from the Swedish national eating disorders quality registers and patient registers to explore clinical characteristics at diagnosis, diagnostic flux, psychiatric comorbidity, and suicide attempts in 850 individuals diagnosed with binge-eating disorder (BED). Method Cases were all individuals who met...

Objective: Characterize the frequency, duration, and severity of binge-eating behaviors in adults meeting DSM-5 criteria for binge-eating disorder (BED) in a large US community sample. Methods: A representative sample of US adults from the National Health and Wellness Survey was recruited from an online panel and asked to respond to an Internet...

Objective: To evaluate associations between binge-eating disorder (BED) and somatic illnesses and determine whether medical comorbidities are more common in individuals who present with BED and comorbid obesity. Method: Cases (n = 850) were individuals with a BED diagnosis in the Swedish eating disorders quality registers. Ten community controls...

The objective of this review was to examine the evidentiary basis for binge eating disorder (BED) with reference to the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) diagnostic criteria for BED. A PubMed search restricted to titles and abstracts of English-language reviews, meta-analyses, clinical trials, randomized...

Objective: Individuals with binge-eating disorder (BED) experience psychiatric and somatic comorbidities and obesity, but the nature and magnitude of prescription medication utilization is unclear. We investigated utilization using Swedish registry data and a case-control design. Methods: Cases were identified from Riksät and Stepwise longitudin...

Objective: Review the clinical skills needed to recognize, diagnose, and manage binge-eating disorder (BED) in a primary care setting. Data Sources: A PubMed search of English-language publications (January 1, 2008-December 11, 2014) was conducted using the term binge-eating disorder. Relevant articles known to the authors were also included. Study...

Objective: To estimate binge eating disorder (BED) prevalence according to DSM-5 and DSM-IV-TR criteria in US adults and to estimate the proportion of individuals meeting DSM-5 BED criteria who reported being formally diagnosed. Methods: A representative sample of US adults who participated in the National Health and Wellness Survey were asked t...

Objective: Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Methods: Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then re...

Purpose: To perform a systematic review of the health-related quality of life (HRQoL) and economic burdens of anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). Methods: A systematic literature search of English-language studies was performed in Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL...

Objectives: Binge eating disorder (BED) - now a designated disorder in the DSM-5 - is the most prevalent eating disorder (ED), affecting 2-3% of the US population. This survey of US physicians assesses how BED is diagnosed, treated and referred. Methods: Internists, family practitioners, obstetrics/gynecologist (OB/GYNs) and psychiatrists were r...

Relatively little is known about the neuropathophysiology of binge-eating disorder (BED). Here, the evidence from neuroimaging, neurocognitive, genetics, and animal studies are reviewed to synthesize our current understanding of the pathophysiology of BED. Binge-eating disorder may be conceptualized as an impulsive/compulsive disorder, with altered...

Binge eating disorder (BED), now recognized as a distinct eating disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, is the most prevalent eating disorder. Although nearly half of individuals with BED are obese, BED also occurs in nonobese individuals. Despite the relatively high percentage of weight loss treatment...

Background: Physician-patient conversations were examined to identify barriers to effective discussions about binge eating disorder (BED) arising from discrepancies in how physicians and patients communicate about BED. Methods: Conversations between suspected or diagnosed BED patients (n = 38) and psychiatrists (n = 11) were recorded and the tra...

Objective Establish the Yale–Brown obsessive compulsive scale modified for binge eating (YBOCS-BE) as a fit for purpose measure of treatment benefit in clinical trials of binge eating disorder (BED).MethodsYBOCS-BE psychometric properties were evaluated with data from a Phase 2 randomized controlled trial of lisdexamfetamine dimesylate in 260 adult...

Objective: Although binge eating disorder (BED) is the most prevalent eating disorder, the impact of untreated BED is underappreciated. This review describes the relationship of BED to physical and mental health, quality of life, and functionality. Data sources: PubMed searches were conducted on March 21, 2014; searches were limited to English-l...

Background: Binge eating disorder (BED) is now a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). However, post-DSM-5 patient profiles and viewpoints on BED diagnosis and treatment remain unclear. This study used a focus group methodology to examine demographic and clinical characteristics, as w...

Evidence on antipsychotic prescribing decisions is limited. This pilot study quantified factors considered in choosing an antipsychotic and evaluated the influence of metabolic status on treatment decisions. Prescribing decisions by 4 psychiatrists were examined based on 80 adult patients initiated on antipsychotic medication diagnosed with schizop...

Objective To evaluate the differential effect of pregabalin and venlafaxine-XR versus placebo on sleep outcomes in non-depressed outpatients with generalized anxiety disorder (GAD). Methods This secondary analysis was based on data from a double-blind trial in which adults who met DSM-IV criteria for GAD were randomized to 8-weeks of flexible-dose...

Objective There appears to be no dose-response effect for pregabalin at doses of 300-600 mg, and a modest dose-response effect in the range of 150-300 mg. The goal of the current investigation was to determine the effect of the starting dose on the speed of onset of anxiolytic efficacy. Methods Data were analyzed from 7 trials of outpatients with...

Aims To assess the impact of insomnia on quality of life (QoL) and functioning in patients with generalized anxiety disorder (GAD), and evaluate the efficacy of pregabalin and venlafaxine-XR in improving sleep and QoL. Methods A double-blind trial in adults who met DSM-IV criteria for GAD, with a HAM-A total score ≥20,randomized to 8-weeks of flex...

Aims To determine the incidence and clinical correlates of functional and quality of life (QoL) impairment in patients with generalized anxiety disorder (GAD), and to evaluate the efficacy of pregabalin and venlafaxine-XR in improving functional outcomes. Methods A double-blind trial in adults who met DSM-IV criteria for GAD, with a HAM-A total sc...

Prior research suggests that SSRIs may have greater efficacy for psychic compared to somatic anxiety, while benzodiazepines show greater somatic efficacy. The goal of this analysis was to evaluate the efficacy of pregabalin (PGB) in treating psychic and somatic symptoms of anxiety. Data were combined from six short-term, double-blind, placebo-contr...

To better understand the efficacy and tolerability of atypical antipsychotics among racial groups, we reviewed data from four short-term (4-6 weeks), fixed-dose, placebo-controlled trials of ziprasidone for black, white, and overall populations of patients with schizophrenia. Efficacy of ziprasidone in the black, white, and overall schizophrenic po...

The objective of this study was to assess the impact of high levels of insomnia on response to pregabalin (PGB) in patients with generalized anxiety disorder (GAD). Pooled data were analyzed from six double-blind, placebo-controlled, 4- to 6-week trials of outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition...

The objective of the study was to evaluate the response of generalized anxiety disorder (GAD) patients with prominent gastrointestinal (GI) symptoms to pregabalin (PGB) treatment. Data were pooled from six double-blind, placebo (PBO)-controlled, 4-6 week trials in outpatients who met Diagnostic and Statistical Manual of Mental Disorders, 4th editio...

The objective of this study was to evaluate the anxiolytic efficacy, and speed of onset of efficacy, of pregabalin (PGB) and venlafaxine-XR (VXR) in patients with generalized anxiety disorder (GAD). In this double-blind trial, outpatients, ages 18-65 years, who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for GAD...

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Searching for your next job is never easy. You generally need all the help you can get. Often, that means working with physician recruiters who have the connections to help you land a great position. But dealing with recruiters can be both rewarding and frustrating. In two ACPE CyberForums facilitated by Barry Herman--one in 1999 and another just a...