Quillivant XR (methylphenidate extended release oral suspension) / Pfizer - LARVOL DELTA

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2028 ➔ Dec 2025 | Trial primary completion date: Jun 2028 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Mar 2028 ➔ Sep 2027 | Trial primary completion date: Jun 2027 ➔ Sep 2027

Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Cognitive Disorders • Epilepsy

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2023 ➔ Jun 2028 | Trial primary completion date: Jun 2023 ➔ Jun 2028

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati | Phase classification: P1/2 ➔ P4 | N=30 ➔ 100

Enrollment change • Phase classification • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Psychiatry

"Quillivant XR کودکان 12-9 سال 4.05 ساعت، نوجوانان 15-13 سال 2ساعت، بزرگسالان 4 ساعت قیمت این دارو بر اساس شرکت سازنده متغیر هست @merck #cancer" (@sait11859965)

Oncology

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2027 ➔ Mar 2028 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Not yet recruiting | Sponsor: VA Office of Research and Development | N=77 ➔ 226 | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati | Trial completion date: Jan 2022 ➔ Aug 2025 | Trial primary completion date: Jan 2022 ➔ Aug 2025

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Psychiatry

".@TevaPharm’s copy of Tris’ chewable extended-release ADHD drug, QuilliChew ER, blocked until 2033 as NJ judge finds infringement of 5 patents. FedCirc in July rejected $TEVA's appeal of ruling its Quillivant XR copy infringed 3 patents for liquid version. https://t.co/NAKnCdeDhC" (@yasiejko)

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Tris Pharma announces U.S. Court of Appeals for the Federal Circuit Affirms Validity of Quillivant XR Patents; Rules Teva Infringes Tris Patents (PRNewswire) - "Tris Pharma...a fully integrated pharmaceutical company with a robust portfolio of CNS products announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision on July 7, 2022 upholding the validity and infringement of various patents relating to Quillivant XR® (methylphenidate HCl)....The CAFC decision confirms the lower court finding and prevents Actavis from launching a generic version of Quillivant XR until the expiration of the patent portfolio providing exclusivity until February 2031."

Patent • CNS Disorders

"سوسپانسیون پیوسته رهش Quillivant XR کودکان 12-9 سال 4.05 ساعت، نوجوانان 15-13 سال 2ساعت، بزرگسالان 4 ساعت@merck #cancer" (@hamed03905919)

Oncology

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2; N=64; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Jun 2021 ➔ Jun 2023; Trial primary completion date: Jun 2021 ➔ Jun 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Children's Hospital Medical Center, Cincinnati; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Psychiatry

DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Children's Hospital Medical Center, Cincinnati; Initiation date: Jan 2020 ➔ Aug 2020

Clinical • Trial initiation date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4; N=77; Not yet recruiting; Sponsor: VA New York Harbor Healthcare System

Clinical • New P4 trial • Alzheimer's Disease • CNS Disorders • Epilepsy • Solid Tumor

DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Children's Hospital Medical Center, Cincinnati

Clinical • New P1/2 trial

Are Differences in Long-Acting Stimulant Formulations Clinically Meaningful? (APSARD 2020) - "Methylphenidate (MPH) ER requires additional PK measures– namely, partial exposure/AUC (pAUC) measures...The main aim of this dose-optimized, double-blind, randomized, placebo-controlled, cross-over analogue classroom study was to address BE in pharmacodynamic (PD) effects between MPH ER formulations intended to be similar in PK (e.g., OROS MPH (Concerta), Mallinckrodt generic) compared to a MPH ER formulation with a different PK profile, Quillivant XR...Learning Objective 1: To gain familiarity on FDA requirements for Bioequivalence in MPH ER formulations. Learning Objective 2: To understand clinical implications of differing PK profiles in MPH ER formulations."

Clinical

Relative Bioavailability of Methylphenidate Extended-release Chewable Tablets Chewed Versus Swallowed Whole. (PubMed, Clin Ther) - "There was no difference in overall rate or extent of exposure of methylphenidate when MPH ERCT was chewed versus swallowed whole by healthy volunteers."

Journal

A Prospective Open-label Trial of Long-Acting Liquid Methylphenidate for the Treatment of Attention Deficit/Hyperactivity Disorder in Intellectually Capable Adults with Autism Spectrum Disorder (AAN 2019) - "Our findings suggest that MPH-ER formulation is very effective and well-tolerated in the treatment of ADHD in adults with high-functioning ASD."

Clinical