Jornay PM (methylphenidate extended release) / Highland Therapeutics - LARVOL DELTA

Medication Treatment of ADHD in Pediatric Epilepsy (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

New P4 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Epilepsy • Pediatrics • Psychiatry

JORNAY PM® enhances ADHD symptom improvement vs other extended-release stimulants in women, without impacting depression or anxiety treatment response (APA 2026) - "Adults with ADHD prescribed any dose of lisdexamfetamine (LDX), amphetamine (AMP) ER, methylphenidate (MPH) ER, or JORNAY PM and ≥2 office visits were included. In adults with ADHD treated with ER stimulants, gender modified treatment response to JORNAY PM for ADHD symptoms measured by the ASSET, a validated symptom tracking scale. No differences between gender or treatments were found for PHQ-9 or GAD-7. The analyses are limited by small sample size and racial diversity of the included population."

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

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: NYU Langone Health | Trial completion date: Jan 2026 ➔ Oct 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

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: Sep 2027 ➔ May 2028 | Trial primary completion date: Sep 2027 ➔ May 2028

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

Treating hearts and minds: adverse cardiovascular effects of psychiatric medications. (PubMed, Ther Adv Drug Saf) - "Increasing QT dispersion and induction of Brugada phenotype, both associated with serious cardiac arrhythmias and sudden death, can occur with certain antipsychotics (e.g. trifluoperazine), certain TCAs (e.g. amitriptyline), certain SSRIs (e.g. fluoxetine), methylphenidate and particular mood stabilisers (e.g. lithium)...It is important to note that pharmacokinetic drug-drug interactions, such as inhibition of the cytochrome P450 (CYP450) system, can affect the pharmacodynamic profile of psychiatric medications, thereby increasing the risk of their associated adverse cardiovascular effects. By understanding the main adverse cardiovascular effects of psychiatric medications and prescribing appropriately, clinicians can reduce potential harm in patients with SMI."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiomyopathy • Cardiovascular • CNS Disorders • Hypertension • Hypotension • Inflammation • Metabolic Disorders • Psychiatry

Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD (clinicaltrials.gov) - P3 | N=26 | Terminated | Sponsor: Ironshore Pharmaceuticals and Development, Inc | N=168 ➔ 26 | Trial completion date: Jul 2026 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2026 ➔ Jul 2025; FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Determining the Optimal Dose of Methylphenidate HCI (Jornay PM) in Adolescents and Adults in a Real-World Psychiatric Setting (AACAP 2025) - "In this retrospective, real-world analysis in adolescents and adults, Jornay PM was effective and well-tolerated. Regression analyses predicted dose stabilization points, suggesting optimal doses of 60 mg for adolescents and 80 mg for adults. This large sample of real-world data provides valuable insights into Jornay PM usage patterns, informing dosing strategies and treatment plans.TREAT, ADOL, RCR"

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

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: NYU Langone Health | Trial completion date: Oct 2025 ➔ Jan 2026 | Initiation date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

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

Real-World Dose Titration Patterns in Children, Adolescents, and Young Adults Treated With Delayed-Release/Extended-Release Methylphenidate (AACAP 2024) - "Objectives: DR/ER-MPH (JORNAY PM®; formerly HLD200) is the first evening-dosed delayed-release and extended-release methylphenidate approved for individuals ≥6 years with ADHD. These real-world data demonstrated that in clinical practice, with patients aged 6 to 29, DR/ER-MPH dose titration patterns differed from those in a phase 3 clinical trial of participants aged 6 to 12. In the trial, participants achieved significant and clinically relevant improvements in ADHD symptoms and reductions in functional impairment from waking to bedtime, with a safety profile consistent with other methylphenidates. These findings suggest an opportunity to improve outcomes by titrating similarly to the clinical trial, in which all-day duration was achieved within 6 weeks.ADHD, STIM, TREAT"

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

Ph3 Multicenter, 3wk RDBPC Efficacy, Safety & PK Study of Evening Dosed MPH HCl ER Capsules (HLD200) in Children 4-5 Yr With ADHD (clinicaltrials.gov) - P3 | N=168 | Recruiting | Sponsor: Ironshore Pharmaceuticals and Development, Inc | Not yet recruiting ➔ Recruiting

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

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

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: NYU Langone Health

New P4 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Ph3 Multicenter, 3wk RDBPC Efficacy, Safety & PK Study of Evening Dosed MPH HCl ER Capsules (HLD200) in Children 4-5 Yr With ADHD (clinicaltrials.gov) - P3 | N=168 | Not yet recruiting | Sponsor: Ironshore Pharmaceuticals and Development, Inc

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

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

A Post-Hoc Analysis of Emotional Lability With Delayed-Release/Extended-Release Methylphenidate in Children Aged 6 to 12 Years of Age Participating in Two Phase 3 Clinical Trials. (PubMed, J Atten Disord) - P3 | "DR/ER-MPH (formerly HLD200) is an evening-dosed delayed-release and extended-release methylphenidate approved for the treatment of ADHD in patients ≥6 years. Few emotional adverse events (AEs) were reported. DR/ER-MPH treatment resulted in statistically significant improvements in EL to the level of non-ADHD peers as contextualized by T-scores."

Journal • P3 data • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Adult and preadolescent methylphenidate leads to changes in sleep/wake activity rhythms in rats (Neuroscience 2023) - "Adult MPH exposure produce circadian rhythm disturbance with shifts in acrophase and amplitude. Additionally, increases in fragmentation of rest-activity during the light period occurred after prolonged withdrawal."

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

Pooled Post Hoc Analysis of Permanent Product Measure of Performance (PERMP) Scores in Children With ADHD Treated With DR/ER-MPH from Two Phase 3 Studies (AACAP 2023) - P3 | "Delayed-release and extended-release methylphenidate (DR/ER-MPH, trade name: JORNAY PM®) is an evening-dosed formulation that provides a dose-dependent duration of effect for individuals aged ≥6 years with ADHD. Significance at the 8 AM time point demonstrates that participants in the DR/ER-MPH group were medicated prior to the start of the classroom study day. Conclusions In a pooled post hoc analysis, DR/ER-MPH significantly improved mean PERMP-CS from 8 AM to 8 PM vs placebo, demonstrating consistent improvement in classroom performance from morning until evening."

Clinical • P3 data • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Development of an Interactive Pharmacokinetic Dose-Dependent Duration Model for Delayed-Release and Extended-Release Methylphenidate (AACAP 2023) - "Objectives Evening-administered delayed-release and extended-release methylphenidate (DR/ER-MPH, trade name: JORNAY PM ® ) is approved for the treatment of ADHD in patients 6 years and older, with efficacy coinciding with awakening and lasting until evening. The HCPs reported that the 3 thresholds were appropriate to capture the durations of effect for the majority of patients, and that patients tended to follow along a given threshold as doses were up-titrated. Conclusions An interactive PK dashboard appropriately illustrated the concept of dose-dependent duration with DR/ER-MPH by applying literature-based thresholds of effective MPH concentrations to an established population PK model."

PK/PD data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Convolution-based In Vitro-In Vivo Correlation (IVIVC) Model for Methylphenidate Hydrochloride Delayed-release and Extended-release Capsule. (PubMed, CPT Pharmacometrics Syst Pharmacol) - No abstract available

Journal • Preclinical

Effects of adolescent methylphenidate administration on methamphetamine conditioned place preference in an animal model of attention-deficit/hyperactivity disorder: Examination of potential sex differences. (PubMed, Drug Alcohol Depend) - "These results demonstrate the importance of considering biological sex when prescribing psychostimulant medications for ADHD as long-term MPH administration may increase the risk of continued drug use in females with ADHD following a period of abstinence."

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

Adverse Events During Dosing of Delayed-Release/Extended-Release Methylphenidate: Learnings From the Open-Label Phase of a Registration Trial and a Real-World Postmarketing Surveillance Program. (PubMed, Clin Ther) - P3 | "No new safety concerns were revealed in this real-world setting compared with the safety profile identified in DR/ER-MPH trial data. In real-world practices, clinicians tended to discontinue DR/ER-MPH treatment after AE onset, whereas trial investigators continued to optimize treatment and found that AEs were generally tolerable, suggesting that health care practitioners may consider developing strategies to manage tolerability issues with DR/ER-MPH treatment on AE emergence rather than immediately discontinuing use of the drug to provide optimal therapeutic benefit."

Adverse events • Journal • P4 data • Real-world • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

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

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

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