dextroamphetamine modified release (HLD-100) / Highland Therapeutics - LARVOL DELTA

Real-World Utilization of Delayed-Release/Extended-Release Methylphenidate: Demographic and Dosing Data from a Large US Claims Database Analysis (CADDRA ADHD 2024) - "Research Funded By: Ironshore Pharmaceuticals, manufacturer of JORNAY PM® (formerly HLD200). A total of 5,501 patients (mean age: 20.2y; 55% male) were included; 17.4% and 24.1% had experience with amphetamine and methylphenidate, respectively, in the prior six months. Most common psychiatric comorbidities were anxiety disorders (26.3%), mood disorders (19.3%), autism spectrum disorder (6.7%), and oppositional defiant disorder (6.7%). For patients with ≥4 DR/ER-MPH prescriptions (N=2,831), mean starting strength was 33.2 mg and 60.2% initiated at 20 mg; mean strength increased to 49.4 mg by prescription four."

Claims database • Clinical • Real-world • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • Behavior Disorders • CNS Disorders • Genetic Disorders • Mood Disorders • Psychiatry

Growth Trajectories of Children and Adolescents With ADHD Treated With Delayed-Release/Extended-Release Methylphenidate (JORNAY PM®): A Pilot Study of Real-World Data From a Large US Claims Database (AACAP 2022) - "Herein, we report real-world weight and height changes in patients newly prescribed DR/ER-MPH in its first year of availability vs patients treated with 2 established branded stimulants, osmotic release oral system (OROS) MPH (Concerta®) and lisdexamfetamine dimesylate (LDX; Vyvanse®)...Differences in weight and height trajectories were modeled with repeated measures mixed effects models (DR/ER-MPH vs OROS MPH or LDX); covariates were baseline weight (height models), baseline height (weight models), age, sex, and prior amphetamine or methylphenidate use...Conclusions Of patients newly prescribed DR/ER-MPH in its first year of availability, growth trajectories after 1 year of treatment numerically increased relative to OROS MPH and LDX, with the weight trajectory significantly increased compared to LDX. Reasons for these growth improvements remain to be investigated."

Clinical • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Higher Persistence with DR/ER-MPH over Other Extended-Release Stimulants for the Management of ADHD: Real World Evidence from a Large Us Claims Database Analysis (CADDRA ADHD 2022) - "DR/ER-MPH (formerly HLD200) is an evening-dosed, delayed-release and extended-release methylphenidate (MPH) that is released in the colon; it has no immediate-release component and provides a dose-dependent duration of effect for individuals with ADHD...Results were stratified by age (6–12y, 13–17y, ≥18y) and prior extended-release (ER) stimulant medication use (amphetamine [AMP], MPH, both, neither)... Persistence over 12 fills was highest with DR/ER-MPH (20% from 19,697 episodes) compared to AMP prodrug (16% from 726,083 episodes), generic ER AMP (15% from 950,593 episodes), branded ER MPH/AMP analogs (11% from 147,440 episodes), and generic ER MPH (8% from 770,454 episodes) (P<0.01 for DR/ER-MPH compared to all other treatments). Age was found to be an important moderator of persistence patterns. Although not adjusted for baseline characteristics, and despite differences in sample sizes, individuals showed higher overall persistence rates over 12 prescription..."

Clinical • HEOR • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Higher Persistence And Adherence With Dr/Er-Mph Over Other Extended-Release Stimulants For The Management Of Adhd: Real-World Evidence From A Large U.S. Claims Database Analysis (AACAP 2021) - "The evening-dosed, delayed-release and extended-release methylphenidate ([DR/ER-MPH]; JORNAY PM®; formerly HLD200) is released in the colon and provides a dose-dependent duration of effect for individuals with ADHD...Persistence and adherence rates for DR/ER-MPH were compared to other extended-release (ER) stimulants using a 2-proportion hypothesis test and right-tailed 2-sample t test, respectively, both with α = 0.01.Results The persistence rate over the 9-month period was highest with DR/ER-MPH at 33% (n = 10,371), compared to 26% for lisdexamfetamine dimesylate (LDX) (n = 384,144), 22% for generic ER amphetamine (ER AMP) (n = 463,429), 20% for branded ER MPH or ER AMP analogs (n = 79,663), and 17% for generic ER MPH (n = 427,396; p < 0.01 for all). Adherence was also highest with DR/ER-MPH at 92%, compared to 89% for LDX, 89% for generic ER AMP, 88% for branded analogs, and 88% for generic MPH (p < 0.01 for all).Conclusions Although not adjusted for..."

Clinical • HEOR • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

HLD100-103: A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD (clinicaltrials.gov) - P2; N=22; Completed; Sponsor: Ironshore Pharmaceuticals and Development, Inc; Active, not recruiting ➔ Completed

Trial completion • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders

Ironshore Pharmaceuticals announces positive HLD100 results from open-label tolerability study in pediatric ADHD patients (Businesswire) - P2, N=22; NCT02884544; Sponsor: Ironshore Pharmaceuticals; "HLD100 was well tolerated with no serious adverse events noted during the study...results showed median values for the SDSC total score and all subscale scores either the same or lower (improved) than at baseline...Ironshore intends to initiate the pivotal trials in the third quarter of 2017, with a New Drug Application expected in 2018."

NDA • New P3 trial • P2 data • Attention Deficit Hyperactivity Disorder • CNS Disorders

Effect of Dextroamphetamine on Poststroke Motor Recovery: A Randomized Clinical Trial. (PubMed, JAMA Neurol) - P2; "The studied treatment regimen was safe. ClinicalTrials.gov identifier: NCT01905371."

Clinical • Journal