David McDonnell, MD

Weight Gain and Treatment Interruptions With Second-Generation Oral Antipsychotics: Analysis of Real-World Data Among Patients With Schizophrenia or Bipolar I Disorder

Among patients with schizophrenia (SZ) and bipolar I disorder (BD-I) treated with second-generation antipsychotics (SGAs), clinically-significant weight gain (CSWG) and treatment interrup...

Hannah Cummings , PhD;

Gregory Donadio , MA;

Thomas Brecht , MS;

Leona Bessonova , PhD;

Amy O'Sullivan , PhD;

David McDonnell , MD;

Jonathan Meyer , MD;

Kathleen Mortimer , ScD, MPH;

Michael Doane , PhD;

Henry Cheng , MA, MPH;

10/08/2020

Phase 3 Safety and Tolerability Results of the Combination Olanzapine and Samidorphan in Patients With Schizophrenia: The 1 Year ENLIGHTEN-2-Extension

Background: Combination olanzapine and samidorphan (OLZ/SAM) is in development for treatment of schizophrenia and bipolar I disorder and is intended to provide the antipsychotic efficacy ...

Bei Yu , PhD;

Craig Hopkinson , MD;

Ying Jiang , PhD;

Christine Graham , PhD;

Bernard Silverman , MD;

Lauren DiPetrillo , PhD;

Adam Simmons , MPH;

David McDonnell , MD;

Rene Kahn , MD, PhD;

Jiani Yin , PhD;

Vasudev Bhupathi , MBA;

10/08/2020

A Combination of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Disorder: Overview of Clinical Data

Objectives: Olanzapine effectively treats schizophrenia and bipolar I disorder (BD-I); however, its use is hindered by significant weight gain. A combination of olanzapine and samidorphan...

Mark Todtenkopf , PhD;

Lauren DiPetrillo , PhD;

Hannah Cummings , PhD;

Leslie Citrome , MD;

Adam Simmons , MPH;

David McDonnell , MD;

Ying Jiang , PhD;

Lei Sun , PhD;

Christine Graham , PhD;

Bernard Silverman , MD;

10/08/2020

A Combination of Olanzapine and Samidorphan Has No Clinically Relevant Effect on QT Prolongation Up to Supratherapeutic Doses

Background: ALKS 3831, a combination of olanzapine and samidorphan (OLZ/SAM) in development for schizophrenia, is intended to mitigate olanzapine-associated weight gain. This thorough QT ...

Lisa L. von Moltke , MD, FCPP;

Lei Sun , PhD;

Sergey Yagoda , PhD, MD;

Hongqu Xue , PhD;

Randy Brown , MS;

Narinder Nangia , PhD;

Bhaskar Rege , PhD, BPharm;

Borje Darpo , MD, PhD;

David McDonnell , MD;

11/22/2019

A Phase 3, Multicenter Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Olanzapine/Samidorphan in Patients With Schizophrenia

Background: ALKS 3831, a combination of olanzapine and samidorphan (OLZ/SAM), is in development for the treatment of schizophrenia and is intended to provide the antipsychotic efficacy of...

Christina Arevalo , MS;

Sergey Yagoda , PhD, MD;

Christine Graham , PhD;

Yangsong Cheng , PhD;

Adam Simmons , MPH;

David McDonnell , MD;

11/22/2019

Insulin Sensitivity and Glucose Metabolism of Olanzapine and Combination Olanzapine and Samidorphan: A Phase 1 Exploratory Study in Healthy Volunteers

Background: A combination of olanzapine and samidorphan (OLZ/SAM) is in development for schizophrenia to provide the efficacy of olanzapine while mitigating olanzapine-associated weight g...

Mark Namchuck , PhD;

John Newcomer , MD;

David McDonnell , MD;

Ying Jiang , PhD;

Christine Graham , PhD;

Linda Morrow , MD;

Carine Beysen , DPhil;

Frederico Toledo , MD;

Daiva Bajorunas , MD;

Bernard Silverman , MD;

11/22/2019

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Patients With Acute Exacerbation of Schizophrenia

Background: ALKS 3831, under development for the treatment of schizophrenia, is composed of olanzapine and samidorphan. In a prior study, samidorphan mitigated olanzapine-associated weigh...

Ying Jiang , PhD;

Bernard Silverman , MD;

Lauren DiPetrillo , PhD;

Steven Potkin , MD;

Adam Simmons , MPH;

David McDonnell , MD;

03/01/2019

Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients With Schizophrenia

Background: An open-label extension study (NCT02873208) evaluated the long-term tolerability, safety, and efficacy of combination olanzapine/samidorphan (OLZ/SAM) treatment in patients wi...

Leona Bessonova , PhD;

Amy O'Sullivan , PhD;

David McDonnell , MD;

Cory Saucier , MPH;

Michelle White , PhD;

April Foster , BS;

Jakob Bjorner , MD, PhD;

Olga Lapeyra , MD, CCRP;

David Walling , PhD, CNS, MD;

Adam Simmons , MPH;

Julia Carpenter-Conlin , MSW;

10/08/2020