methylphenidate modified release capsules - 8 hrs acting / Generic mfg. - LARVOL DELTA

"These include brand name (= Generic version): - @VYVANSE (Lisdexamfetamine) - Concerta, Ritalin LA, Daytrana, etc (Methylphenidate) - Focalin ER (Dexmethylphenidate ER) @Novartis - Adderall XR - Dexedrine, etc (Dextroamphetamine) - Azstarys These last 12 hours or longer" (@RTorof)

FASST - Fetal Alcohol Spectrum Stimulant Trial (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: Monash Medical Centre | Trial completion date: Dec 2022 ➔ Jul 2023 | Trial primary completion date: Jul 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • 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 قبل از مراجعه به داروخانه‌ها حتما با آنها تماس بگیرید @merck #bleeding"" (@rahadani1)

A Simulation Study of the Comparative Performance of Partial Area under the Curve (pAUC) and Partial Area under the Effect Curve (pAUEC) Metrics in Crossover Versus Replicated Crossover Bioequivalence Studies for Concerta and Ritalin LA. (PubMed, AAPS J) - "Ritalin LA pAUC values were insensitive to increases in either ratio once the ratio exceeded 1.0 and the study design. Correlations between least squares means (LSM) for pAUC and the SKAMP pAUEC for the composite scores were near 90%."

Journal

""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)

FASST - Fetal Alcohol Spectrum Stimulant Trial (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: Monash Medical Centre | Not yet recruiting ➔ Recruiting | N=40 ➔ 20 | Trial completion date: Jun 2022 ➔ Dec 2022 | Initiation date: Jul 2021 ➔ Feb 2022 | Trial primary completion date: Feb 2022 ➔ Jul 2022

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

"@NovartisTurkiye Ritalin LA ne zaman satışa çıkacak?" (@YusufCakarTw)

FASST - Fetal Alcohol Spectrum Stimulant Trial (clinicaltrials.gov) - P4; N=40; Not yet recruiting; Sponsor: Monash Medical Centre

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

".@TevaUSA reintroduces #generic Ritalin LA https://t.co/ihKgS1yeme" (@PDXInc)

Biosimilar

Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders (clinicaltrials.gov) - P4; N=5; Terminated; Sponsor: Sheba Medical Center; N=70 ➔ 5; Recruiting ➔ Terminated; Major difficulties recruiting participants

Clinical • Enrollment change • Trial termination

Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder. (PubMed, J Child Adolesc Psychopharmacol) - "Results demonstrate MPH-MLR efficacy in preschool children and a safety profile consistent with known AEs of methylphenidate when used for ADHD."

Clinical • Journal

FDA spanks KVK Tech over impurities in ADHD drug (Fierce Pharma) - "The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with an ADHD drug...The FDA, in a warning letter posted this week...The letter also found problems with the plant’s investigation of foreign particles found in a lot of the ADHD drug methylphenidate oral solution."

FDA event

Psychiatric Comorbidities in Adult Attention-deficit/Hyperactivity Disorder: Prevalence and Patterns in the Routine Clinical Setting. (PubMed, Innov Clin Neurosci) - " Data obtained from postmarketing surveillance of methylphenidate extended-release tablets for adult ADHD were used to evaluate the prevalence of psychiatric comorbidities. Psychiatric comorbidities have a high prevalence in patients with adult ADHD. Understanding these patterns could provide useful information in the diagnosis of adult ADHD and future investigations of its etiology."

Clinical • Journal

A Phase 4, Open-Label, Single-Dose Pharmacokinetic Study of a Novel Methylphenidate Extended-Release Orally Disintegrating Tablet Formulation in Preschool-Aged Children (APSARD 2020) - "MPH XR-ODT was well tolerated in preschool-aged children. Peak plasma concentration of and exposure to d-MPH were significantly greater than those of l-MPH, and d‑MPH had a longer half-life, consistent with previous studies of oral MPH."

Clinical • P4 data • PK/PD data

Dexmethylphenidate Extended Release-Associated Orofacial Dyskinesia in an Adolescent with Autism Spectrum Disorder After Prolonged Use. (PubMed, J Child Adolesc Psychopharmacol) - No abstract available.

Journal

Optimization of Methylphenidate Extended-Release Chewable Tablet Dose in Children with ADHD: Open-Label Dose Optimization in a Laboratory Classroom Study. (PubMed, J Child Adolesc Psychopharmacol) - "Dose-optimization period results describing relationships between change in ADHD symptom scores and final optimized MPH ERCT dose will be valuable for clinicians optimizing MPH ERCT dose."

Clinical • Journal

Relationship Between Symptomatic and Functional Improvement and Remission in a Treatment Response to Stimulant Trial. (PubMed, J Child Adolesc Psychopharmacol) - "Children and adolescents treated with MPH-MLR showed moderate-to-large improvement in functioning during 3 months of treatment, both overall and in specific domains. However, a significant number of those who would be considered symptomatic responders failed to show improvement in functioning or continue to have significant functional impairment. Treatment with MPH-MLR showed that both symptomatic and functional remission are achievable goals. Identification of children and adolescents who have been successfully treated for their symptoms, but continue to suffer functional impairment, will allow us to offer additional targeted treatment interventions over and above medication to address residual difficulties."

Clinical • Journal

A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants. (clinicaltrials.gov) - P4; N=8; Recruiting; Sponsor: Massachusetts General Hospital; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Granules India announces USFDA approval for methylphenidate hydrochloride extended release capsules (Business Standard) - "Granules India announced that the United States & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA)...for Methylphenidate Hydrochloride Extended-Release capsules for 10 mg, 20 mg, 30 mg, 40 mg and 60 mg..."

ANDA

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

Methylphenidate ER Toxicity With Awake Bruxism in a Six-Year-Old Boy (APA 2019) - "He was initially started on methylphenidate extended release (ER) 18mg by mouth every morning, which was increased after three weeks to methylphenidate ER 27mg. This poster will review the literature on this rare presentation, with particular focus on the bruxism. Better understanding of this topic will lead to improved safety and patient care."

Delayed Onset of Severe Dystonic Reaction With Intramuscular Haloperidol in a Child: A Case Report (APA 2019) - "The patient had been receiving scheduled medications of escitalopram, clonidine, oxcarbazepine, and was recently started on dexmethylphenidate extended release after completing an atomoxetine taper. Additionally, there was absence of symptoms concerning for extrapyramidal side effects prior to this delayed dystonic reaction. This case illustrates the challenges and importance of diagnosing and assessing in children for potential risk of developing delayed onset dystonic reactions from intramuscular haloperidol or other high-potency neuroleptics."

Clinical

Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release. (PubMed, J Clin Med) - "This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint."

Clinical • Journal

A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants. (clinicaltrials.gov) - P4; N=8; Not yet recruiting; Sponsor: Massachusetts General Hospital

Clinical • New P4 trial

Drug approval reports (FDA) - Novartis' Ritalin LA label approved on 01/10/2019.

sNDA