NOVEN TO PRESENT DATA FOR: EXTRAPOLATING PEDIATRIC TRANSDERMAL ADHD TREATMENT EFFICACY DATA TO ADULT POPULATIONS AND CORRELATING TREATMENT EFFECT DURATION WITH PATCH WEAR TIMES AT AMERICAN PSYCHIATRIC NURSES ASSOCIATION ANNUAL CONFERENCE – QNT Press Release

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–First study extrapolates efficacy of transdermal dextroamphetamine from pediatric to adult populations–

–Second study explores variations in patch wear-times–

MIAMI and JERSEY CITY, NJ, Oct. 17, 2022 /PRNewswire/ — Noven Pharmaceuticals. Inc., (Noven), a wholly owned subsidiary of Hisamitsu Pharmaceutical Co., Inc. focusing on the development of transdermal therapy, announced today it will present the results of two pharmacokinetic (PK) modeling datasets at the 36th American Psychiatric Nurses Association (APNA) annual conference in Long Beach, California October 19-22, 2022. The data discusses the investigation of variable wear times for the dextroamphetamine transdermal system (d-ATS) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and extrapolation of efficacy of d-ATS from pediatric and adolescent patients to adults respectively.

In the “Investigation of Variable Wear Times for the d-ATS System Using Population Pharmacokinetic-Pharmacodynamic Modeling”, a population PK model was developed to describe amphetamine disposition following d-ATS administration. To characterize the onset and duration of effect after d-ATS administration, this model was used to construct a population PK/PD model utilizing SKAMP total score data from the following two pediatric clinical studies:

  • PK/PD clinical pharmacology study (single-dose, open-label) in children 6-12 years of age with ADHD
  • Randomized, double-blind, placebo-controlled efficacy and safety study in children and adolescents 6-17 years of age with ADHD

The d-ATS exposure-response relationship and potential impact of d-ATS wear time (4-9 hours) under different assumptions for amphetamine absorption post-removal were explored through simulation.

“Based on these results, our d-ATS treatment will give our patients a new option for ADHD symptom management,” said presenter Kanan BalakrishnanPharm.D., Executive Director of Regulatory Affairs, Product Development at Noven.

Similarities in pathophysiology, disease state characteristics, and treatment outcomes between pediatric and adult ADHD patients have been demonstrated. Furthermore, post-marketing experience and published evidence support a tight link between the pharmacodynamic effects of amphetamines (AMP) and their pharmacokinetic (PK) profile in attention-deficit/hyperactivity disorder (ADHD). In the research, “Extrapolation of the Efficacy of a Dextroamphetamine Transdermal System Investigated in Pediatric Populations to Adults Using Pharmacokinetic Modeling” the established d-ATS PK model was used to simulate exposures at the doses tested in the pivotal pediatric study (ATS 5mg/9hours, 10mg/9hours, 15mg/9hours and 20mg/9hours equivalent to the approved XELSTRYM 4.5mg/9hours, 9mg/9hours, 13.5mg/9hours and, 18mg/9hours dose, respectively) and compare them to adult exposures at the same doses.

The simulated data demonstrated that amphetamine disposition was comparable for adult and pediatric ADHD populations after accounting for body size effects and that 20-mg d-ATS (equivalent to the XELSTRYM 18mg/9hour dose strength) in adults produced exposures comparable to 15-mg d -ATS (equivalent to the approved XELSTRYM 13.5mg/9hour dose strength) in pediatric patients, the dose demonstrated as efficacious and deemed optimal in the pivotal study.

“The comparable d-ATS exposures and pharmacokinetic profile across patient populations supports the extrapolation of efficacy findings from pediatrics to adults demonstrating that adults are likely to yield efficacy and safety results similar to those observed in the pivotal pediatric trial,” said presenter Mariacristina CastelliMD, Chief Clinical and Regulatory Officer at Noven. “This is an important step in showcasing that efficacy data for d-ATS can apply across age groups.”

Time and location for each presentation is listed below:

  • Poster Title: Extrapolation of the Efficacy of a Dextroamphetamine Transdermal System Investigated in Pediatric Populations to Adults Using Pharmacokinetic Modeling
  • Open to View:
    • Thursday, October 20th from 10:00 AM6:30pm PT / 1:00pm9:30pm ET
    • Friday, October 21st from 10:00 AM3:00pm PT / 1:00pm6:00pm ET

    Full story available on Benzinga.com

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