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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, N.J., 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:
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 Balakrishnan, Pharm.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 Castelli, M.D., 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:
"As the developers of the first amphetamine transdermal patch approved for ADHD in the U.S., we are pleased to offer the ADHD community a treatment that will allow clinicians, alongside their patients, to individualize their treatment experience,1" said Joel Lippman, M.D., Chief Operating Officer and Chief Medical Officer at Noven. "We wanted our product to reflect that when it comes to treating patients with ADHD, there isn't a one-size-fits-all solution."
Approved this year by the FDA for Adults and Children with ADHD six years' age and older, Noven's d-ATS system will be available in 2023 for prescription under the brand name XELSTRYM™.
To learn more about XELSTRYM and stay abreast of the latest news and updates, register at https://www.xelstrym.com/.
About Attention Deficit Hyperactivity Disorder (ADHD)
ADHD is one of the most common neurodevelopmental disorders of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. ADHD can last into adulthood. Some adults have ADHD but have never been diagnosed. The symptoms can cause difficulty at work, at home, or with relationships. Symptoms can become more severe when the demands of adulthood increase and may look different at older ages, for example, hyperactivity may appear as extreme restlessness.
About XELSTRYM™
XELSTRYM is the first and only FDA-approved, once-daily amphetamine transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. XELSTRYM should be applied 2 hours before an effect is needed and removed within 9 hours after application.
IMPORTANT SAFETY INFORMATION
What is XELSTRYM?
XELSTRYM is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older. It is not known if XELSTRYM is safe and effective in children younger than 6 years of age.
IMPORTANT SAFETY INFORMATION
Abuse and dependence: XELSTRYM, other amphetamine-containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider (HCP) should check you or your child for signs of abuse and dependence before and during treatment with XELSTRYM.
XELSTRYM is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep XELSTRYM in a safe place to protect it from theft. Never sell or give your XELSTRYM to anyone else because it may cause death or harm to them and it is against the law.
Do not use XELSTRYM if you or your child are:
XELSTRYM can cause serious side effects, including:
Before taking XELSTRYM tell your healthcare provider if you:
What should I avoid while using XELSTRYM?
What are the possible side effects of XELSTRYM?
Please read the Medication Guide and Full Prescribing Information including the Boxed Warning.
To report suspected Adverse Reactions, contact Noven at 1-800-455-8070 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
There is a pregnancy registry for women who are exposed to XELSTRYM during pregnancy. The purpose of the registry is to collect information about the health of women exposed to XELSTRYM and their baby. If you or your child becomes pregnant during treatment with XELSTRYM, talk to your HCP about registering with the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/
XEL-5008-16 (2.0)
10/2022
About Noven Pharmaceuticals, Inc.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven's mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. Noven is a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as Hisamitsu's U.S. platform for prescription pharmaceuticals, and helping Hisamitsu bring the benefits of patch therapy to the world. For more information about Noven, visit http://www.noven.com. For information about Hisamitsu, visit https://global.hisamitsu.
Contact:
Natalie Andrade
Manager – Communications
305-282-7950
corporateaffairs@noven.com
1 XELSTRYM™ should be removed within nine hours after application. Dose titration and final dosage should be individualized depending on clinical response and tolerability
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SOURCE Noven Pharmaceuticals, Inc.