d-amphetamine transdermal drug delivery system (d-ATS) / Hisamitsu, Takeda - LARVOL DELTA

Drug Shortages for Prescription Amphetamine Derivatives. (PubMed, J Pediatr Pharmacol Ther) - "Shortages for amphetamine derivatives have increased recently, limiting access to first-line therapy for ADHD. Inaccessibility of these agents can have negative implications for the cognitive development and functioning of children and adolescents, leading to comorbid mental health disorders."

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

Clinically Meaningful Score Difference (MSD) and Meaningful Score Regions (MSR) in ADHD Rating Scale IV (ADHD-RS-IV) Total Score From Post Hoc Analyses of the Dextroamphetamine Transdermal System (d-ATS) Pivotal Clinical Trial (AACAP 2024) - "In this analysis of MSD in ADHD-RS-IV total score in patients with ADHD, a change of −25 or a percent change of −67% was identified as the clinically MSD of change in ADHD-RS-IV total score from baseline to Week 5. The MSR of change and percent change in ADHD-RS-IV were identified between −38 and −14 points and −87% and −51%, respectively, for those identified as moderately, markedly, and severely ill at baseline. Knowing the MSD and MSR provides an estimate of the expected treatment effect for ADHD patients in a given population and can be used as a threshold to identify individual patients with clinically meaningful improvement.ADHD"

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

A critical review of the dextroamphetamine transdermal system for the treatment of ADHD in adults and pediatric patients. (PubMed, Expert Rev Neurother) - "However, dermal discomfort must be considered in addition to the usual amphetamine side effects when prescribing the d-ATS. Patient and provider experience will determine how frequent the use of d-ATS becomes."

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

Evaluation of Dermal Irritation with the Dextroamphetamine Transdermal System (d-ATS) in Healthy Adults and Patients With ADHD (AACAP 2023) - "Conclusions These results support previous findings that d-ATS is safe and well-tolerated for ADHD. After intended use, irritation was minimal and did not cause study discontinuations."

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

d-Amphetamine Transdermal System in Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Secondary Endpoint Results and Post Hoc Effect Size Analyses from a Pivotal Trial. (PubMed, J Child Adolesc Psychopharmacol) - P2 | "d-ATS was safe and well tolerated, with minimal dermal reactions. Clinical Trial Registration: NCT01711021."

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

Transdermal dextroamphetamine (Xelstrym) for ADHD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Population Pharmacokinetic-Pharmacodynamic Modeling of Variable Wear Times for a Dextroamphetamine Transdermal System (AACAP 2022) - "Conclusions Simulation results suggest that the duration of d-ATS efficacy may be related to wear time, which can be adjusted according to treatment needs, consistent with published observations for another transdermal stimulant. The ability to control exposure offered by a transdermal patch allows treatment duration to be individualized, providing additional flexibility in optimizing ADHD treatment."

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

Extrapolation of Efficacy of a Dextroamphetamine Transdermal System from Pediatric to Adult Populations Using Pharmacokinetic Modeling - "A PopPK model was developed to reasonably characterize AMP disposition across adult and pediatric ADHD populations. The only descriptor needed to differentiate the populations was body size. 20 mg d-ATS in adults produced exposures comparable to 15 mg in pediatric patients, demonstrated as efficacious and deemed optimal in the pivotal study."

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

Effect Size and NNT of the Dextroamphetamine Transdermal System (D-ATS) for ADHD in Children and Adolescents: Post Hoc Analysis of a Pivotal Study (APA 2022) - "Conclusions : This post hoc analysis showed that d-ATS is efficacious for treatment of ADHD in children and adolescents. d-ATS efficacy is comparable to oral d-amphetamine preparations, with a similar effect size and NNT observed with transdermal delivery."

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

d-Amphetamine Transdermal System in Treatment of Children and Adolescents with ADHD: Secondary Endpoint Results from a Phase 2 Trial. (PubMed, CNS Spectr) - "d-ATS was effective in the treatment of ADHD in children and adolescents, meeting its primary endpoint (reported elsewhere) and all secondary endpoints. d-ATS was safe and well-tolerated, with minimal dermal reactions."

Journal • P2 data • ADHD (Impulsive Aggression) • Anorexia • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pain • Psychiatry

Efficacy and Safety of Dextroamphetamine Transdermal System for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results from a Pivotal Phase 2 Study. (PubMed, J Child Adolesc Psychopharmacol) - P2 | "These data indicate that d-ATS can deliver sustained levels of efficacy along with the advantages of transdermal drug delivery, making it a beneficial new treatment option. Clinical Trial Registration no.: NCT01711021."

Clinical • Journal • P2 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

D-Amphetamine Transdermal System (D-Ats) In The Treatment Of Children And Adolescents With Adhd: Secondary Endpoint Results From A Phase 2 Trial (AACAP 2021) - "No patients discontinued due to dermal reactions across both phases.Conclusions d-ATS was effective in the treatment of ADHD in children and adolescents, meeting its primary endpoint (reported elsewhere) and all secondary endpoints. d-ATS was safe and well tolerated, with minimal dermal reactions.ADHD, RCT, STIM"

Clinical • P2 data • ADHD (Impulsive Aggression) • Anorexia • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pain • Psychiatry

[VIRTUAL] Efficacy and Safety of a Dextroamphetamine Transdermal System in the Treatment of Children and Adolescents With ADHD: Results From a Phase 2 Trial (APA 2021) - "d-ATS is efficacious for the treatment of ADHD in children and adolescents and met both its primary and key secondary endpoints. d-ATS was safe and well tolerated, showing a similar systemic safety profile to oral amphetamines. This study was supported by Noven Pharmaceuticals, Inc."

Clinical • P2 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Psychiatry • Sleep Disorder

dATS: Irritation and Sensitization Study of d-Amphetamine Transdermal System (clinicaltrials.gov) - P1; N=229; Completed; Sponsor: Noven Therapeutics; Recruiting ➔ Completed

Trial completion

dATS: Irritation and Sensitization Study of d-Amphetamine Transdermal System (clinicaltrials.gov) - P1; N=200; Not yet recruiting; Sponsor: Noven Therapeutics

Clinical • New P1 trial