Manoj Malhotra, MD

Post hoc Analysis of the Efficacy and Safety of Lemborexant in Adults with Insomnia Disorder and Depression History

Introduction: Study 303 (SUNRISE-2; NCT02952820) evaluated lemborexant (LEM) efficacy in subjects with insomnia. This post-hoc analysis examined sleep outcomes in the subgroup of subjects...

Larry Culpepper , MD;

Andrew Krystal , MD;

Jane Yardley , PhD;

Kate Pinner , MSc;

Naoki Kubota ;

Margaret Moline , PhD;

Jess Amchin , MD, JD;

Norman Atkins Jr., MBA, PhD;

Manoj Malhotra , MD;

Andrew Nierenberg , MD, MGH;

10/08/2020

Impact of Lemborexant on Patient-Reported Insomnia-Related Worry/Distress and Interference With Daily Functioning Over 6 Months: Results From SUNRISE-2

INTRODUCTION: The insomnia severity index (ISI) is a self-report instrument that evaluates perception of insomnia severity. In Study 303 (SUNRISE-2), lemborexant (LEM) showed greater red...

Rakesh Jain , MD, MPH, RD;

Jane Yardley , PhD;

Kate Pinner , MSc;

Manoj Malhotra , MD;

Margaret Moline , PhD;

Norman Atkins Jr., MBA, PhD;

Craig Chepke , MD, DFAPA;

10/08/2020

Lemborexant and suvorexant for treating insomnia: An indirect comparison using number needed to treat, number needed to harm, and likelihood to be helped or harmed

Introduction: Lemborexant is approved in the US for treating insomnia in adults. We evaluated the evidence-base for lemborexant and suvorexant, both dual orexin receptor antagonists (DORA...

Timothy Juday , PhD, MPA;

Norman Atkins Jr., MBA, PhD;

Feride Frech , PhD, MPH;

Leslie Citrome , MD;

Manoj Malhotra , MD;

10/08/2020

Effect of Lemborexant Treatment Across 12 Months on Fatigue Severity and Sleep Outcomes in Subjects With Clinically Significant Fatigue at Baseline

Introduction: The Fatigue Severity Scale (FSS) assesses impact of fatigue on patients’ lives. Lemborexant (LEM) efficacy was examined in the subgroup of subjects with baseline FSS total s...

Norman Atkins Jr., MBA, PhD;

Craig Chepke , MD, DFAPA;

Rakesh Jain , MD, MPH, RD;

Jane Yardley , PhD;

Manoj Malhotra , MD;

Kate Pinner , MSc;

Margaret Moline , PhD;

10/08/2020

Circulating tumor DNA for early relapse detection and monitoring disease status in patients with early-stage pancreatic adenocarcinoma

Background Pancreatic adenocarcinoma (PDAC) is one of the most aggressive cancer histologies, as evidenced by high recurrence rate (85%) and poor 5-year overall survival...

M. Abdelrahim ;

A. Esmail ;

T. Katz ;

S. Sharma , MD;

E. Kalashnikova ;

Manoj Malhotra , MD;

P. Olshan ;

P. Billings ;

A. Aleshin ;

06/28/2021