Noven to Present Pivotal Study Results for Investigational Dextroamphetamine Transdermal System for Pediatric ADHD Patients

MIAMI & JERSEY CITY, NJ – (BUSINESS WIRE) – Noven Pharmaceuticals, Inc., (“Noven”), a wholly owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., announced today that it will present the results of a multicenter phase 2, laboratory classroom study evaluating the safety and efficacy of the experimental dextroamphetamine transdermal system (“ATS”) in more than 100 pediatric patients (ages 6-17 years) with ADHD at the annual meeting of the Virtual American Psychiatric Association (APA) in May 2021.1-3, 2021.

Results of the study, entitled “A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System”, will be presented in the APA Annual Virtual Poster Room Meeting. . The study was designed to evaluate the efficacy and safety of ATS in pediatric patients 6-17 years of age with ADHD compared to placebo.

In a lab classroom, patients who received study ATS showed a significant improvement over placebo in ADHD symptoms, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) total score (difference in LS means (95% CI) of ATS versus placebo was -5.87 (-6.76, -4.97, p <0.001)), which was the primary endpoint. A secondary goal of the study was to assess the onset of ATS efficacy compared to placebo. Initial onset of ATS activity was observed 2 hours after dosing and continued for all time points after dosing up to 12 hours after dosing. The most common adverse reactions were decreased appetite, headache, insomnia, affect lability, upper abdominal pain, vomiting and nausea.

Details for the upcoming presentation are listed below:

Session information

Poster Title: Efficacy and Safety of a Dextroamphetamine Transdermal System in the Treatment of Children and Adolescents with ADHD: Results of a Phase 2 Trial Session: Poster Session 9 Date: Monday, May 3, 2021 Time: 11:00 AM – 11:30 AM EST Poster: P9-066

“We are delighted to present the results of this study. ADHD is one of the most common mental health problems in the US. Currently, no amphetamine-based transdermal treatment option is available for patients with ADHD, ”said poster presenter Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and Chief Medical Officer at the Neuroscience Education Institute.

“In February, Noven announced the filing of a new drug application with the US Food and Drug Administration for its ATS for research,” said Joel Lippman, MD, Chief Operating Officer and Chief Medical Officer, Noven Pharmaceuticals, Inc. ATS would be the first transdermal amphetamine patch approved in the US for ADHD ”

ATS is a research agent and is not currently approved for use in any country. It is currently under review by the United States Food and Drug Administration.

About Attention Deficit Hyperactivity Disorder (ADHD)

ADHD is one of the most common neurodevelopmental disorders in childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behavior (being able to act without thinking about what the outcome will be), or being overly active. ADHD can persist into adulthood. Some adults have ADHD but have never been diagnosed. The symptoms can cause problems at work, at home, or in relationships. Symptoms may become more severe as the demands of adulthood increase and may look different in old age, for example, hyperactivity may appear as extreme restlessness.

About Noven Pharmaceuticals, Inc.

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, production, 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., which serves as Hisamitsu’s US prescription drug platform and helps Hisamitsu bring the benefits of patch therapy to the world. For more information about Noven, visit http://www.noven.com/. Visit https://global.hisamitsu/ for information about Hisamitsu.

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