methylphenidate extended release capsule / Generic mfg. - LARVOL DELTA

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

Drug Delivery Strategies for the Management of Attention-deficit/Hyperactivity Disorder (ADHD): A Case of Differentiated Product Development of Methylphenidate. (PubMed, Recent Adv Drug Deliv Formul) - "The advent of innovative formulations like methylphenidate hydrochloride extendedrelease oral suspension (Quillivant ER) and methylphenidate hydrochloride multilayer extendedrelease capsules (Aptensio XR) addresses challenges in pediatric medication administration. Recent additions like the orally disintegrating tablet (Cotempla X-ODT) offer convenience and flexibility. Understanding the pharmacokinetics, pharmacodynamics, and benefits of these formulations enhances the ability to tailor ADHD treatment to individual patient needs."

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

Evening Quality of Life in Adults with ADHD following Treatment with PRC-063 or Lisdexamfetamine (CADDRA ADHD 2024) - "Objective: To examine the impact in evening-related quality of life in adults with ADHD following treatment with PRC-063 (methylphenidate hydrochloride controlled-release capsules) and lisdexamfetamine (LDX), as used in real-world clinical practice. The results of this real-world study confirm that dose optimized treatment with long-acting stimulants can result in improved evening quality of life within 1 month and maintained out to 4 months in adults with ADHD. Application to clinical and/or educational practice 1. Identify the greatest evening-related quality of life challenges in untreated adult ADHD."

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

Post-Hoc Analysis of Clinical Data by Gender in Adults, Adolescents and Children with ADHD (CADDRA ADHD 2024) - "Objective: To conduct a post-hoc analysis of clinical data on PRC-063 (methylphenidate hydrochloride controlled-release capsules) by gender in adults and children with ADHD. When clinical data was summarized by gender, male and female participants were of similar age and baseline ADHD severity. Both male and female participants had similar optimized daily doses of PRC-063 and had similar improvements in ADHD symptomatology. Participant gender did not lead to a differential response to PRC-063."

Clinical data • Retrospective data • 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

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

Amphetamine and methylphenidate potential on the recovery from stroke and traumatic brain injury: a review. (PubMed, Rev Neurosci) - "We used PubMed as a database and included the following keywords ((methylphenidate) OR (Ritalin) OR (Concerta) OR (Biphentin) OR (amphetamine) OR (Adderall)) AND ((stroke) OR (brain injury) OR (neuroplasticity)). Clinical trials have demonstrated that, depending on the brain region, there is an increase in motor activity, attention, and memory due to the stimulation of the functionally depressed catecholamine system and the activation of neuronal remodeling proteins. Nevertheless, more clinical trials and pre-clinical studies are needed to understand the drugs' full potential for their use in these brain diseases namely, to ascertain the treatment time window, ideal dosage, long-term effects, and mechanisms, while avoiding their addictive potential."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder • Vascular Neurology

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 Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD. (PubMed, J Atten Disord) - "The incidence of treatment-emergent adverse events was similar for each treatment sequence. PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured."

Clinical • Journal • P3 data • 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

Real-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate. (PubMed, J Atten Disord) - "Significant improvements were demonstrated in quality of life and functionality. Both medications were well-tolerated; more adverse events led to study discontinuation in pediatric subjects treated with LDX versus PRC-063. PRC-063 and LDX significantly improved ADHD symptomatology and functioning and were well-tolerated."

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

Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials. (PubMed, J Atten Disord) - "A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults. PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents."

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

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

""کپسول کنترل رهش Biphentin (کودکان 2.4 ساعت، بزرگسالان 2.1 ساعت)، Foquest (بزرگسالان 3.25±6.95) کپسول پیوسته رهش 7-4 ساعت (Ritalin LA کودکان 4-1.5 ساعت، بزرگسالان 4.2-3 ساعت) قرص جویدنی پیوسته رهش 5.2 ساعت قبل از مراجعه به داروخانه‌ها حتما با آنها تماس بگیرید @merck #bleeding"" (@rahadani1)

Phase IV, Pragmatic, Open-Label, Real World Evidence Study of Methylphenidate Hydrochloride Controlled-Release Capsules (PRC-063) and Lisdexamfetamine Dimesylate for Treatment of Pediatric and Adult ADHD (CADDRA ADHD 2022) - "The results of this real-world study confirm that PRC-063 and LDX were effective and well-tolerated treatments for patients with ADHD. Between-treatment imbalance in baseline characteristics may have affected non-inferiority results. The side effect profiles were similar between treatments and between patient populations."

Clinical • HEOR • P4 data • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder

Secondary Outcomes in a Pragmatic, Real World Evidence Study of Methylphenidate HCl (PRC-063) and Lisdexamfetamine Dimesylate for Treatment of Pediatric and Adult ADHD (CADDRA ADHD 2022) - "The real-world secondary outcomes confirm that both PRC-063 and LDX were effective and well-tolerated treatments for patients with ADHD. Significant improvements in functional outcomes related to daily activities, evening quality of life and patient satisfaction were reported."

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

Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults With ADHD. (PubMed, J Atten Disord) - "When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency. PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD."

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

""کپسول کنترل رهش Biphentin (کودکان 2.4 ساعت، بزرگسالان 2.1 ساعت)، Foquest (بزرگسالان 3.25±6.95) کپسول پیوسته رهش 7-4 ساعت (Ritalin LA کودکان 4-1.5 ساعت، بزرگسالان 4.2-3 ساعت) قرص جویدنی پیوسته رهش 5.2 ساعت"@merck #bleeding" (@hamed03905919)

Comparison Of Adhansia Xr And Concerta Pharmacokinetic Profiles (AACAP 2021) - "Objectives Data were collected for PRC-063 (marketed as Adhansia XR® in the United States) 70 mg and OROS methylphenidate (Concerta®) 72 mg in a phase 1 randomized single-dose crossover bioavailability study in adults. Despite the lower Cmax, the AUC from 12 to 16 hours postdose was higher for Adhansia XR (AUC12-16 = 30,479 [8821] h*pg/mL) than for Concerta (AUC12-16 = 22,823 [6884] h*pg/mL; p < 0.01) due to the slower rate of elimination of Adhansia XR during that time interval. The terminal half-lives of Adhansia XR (t1/2z = 4.62 [2.49] h) and Concerta (t1/2z = 4.26 [1.29] h; p = 0.60) were similar to each other.Conclusions Significant differences observed in the PK profiles of 2 extended-release methylphenidate products may lead to differences in onset and duration of ADHD symptom management.ADHD, PKS, STIM"

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

Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD (clinicaltrials.gov) - P4; N=10; Completed; Sponsor: Rhodes Pharmaceuticals, L.P.; Recruiting ➔ Completed; N=60 ➔ 10

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

EF003: A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD (clinicaltrials.gov) - P4; N=132; Completed; Sponsor: Rhodes Pharmaceuticals, L.P.; Not yet recruiting ➔ Completed

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

[VIRTUAL] Dose and Adverse Events of PRC-063 (Multi-Layer, Controlled-Release Methylphenidate Hydrochloride) in Children 6-8 Years of Age with ADHD: A Post-Hoc Analysis of a Phase III Laboratory Classroom Study (CADDRA ADHD 2021) - "AEs were consistent with those reported for other methylphenidate treatments. Three Learning Objectives 1 CADDRA 2021 After this presentation, participants should be better able to: Evaluate the dose range of PRC-063 in children 6-8 years of age during the 6-week open label titration period of a laboratory classroom study Recognize the common adverse events observed in children 6-8 years of age receiving PRC-063 during a 6-week open label titration period of a laboratory classroom study Assess the clinical significance of weight changes in children 6-8 years of age receiving PRC-063 during a 6-week open-label titration period of a laboratory classroom study Research Funded By: Purdue Pharma (Canada)"

Adverse events • Clinical • P3 data • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Psychiatry • Sleep Disorder

Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. (PubMed, J Child Adolesc Psychopharmacol) - P3 | "Sleep efficiency (time asleep as a proportion of time in bed) showed improvement at the end of the OLE study. While individual patients may experience changes in sleep as an adverse event, group data evaluating sleep as an outcome found there were no differences between PRC-063 and placebo in self-reported sleep outcomes on the PSQI."

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