NOVEN ANNOUNCES COMMENCEMENT OF PHASE 2 STUDY OF INVESTIGATIONAL d-AMPHETAMINE TRANSDERMAL SYSTEM FOR ADHD
Miami, FL and New York, NY -- Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced commencement of a Phase 2 study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no approved amphetamine-based transdermal treatment option available for ADHD. The Phase 2 study is a randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of d-ATS compared to placebo in subjects between 6 and 17 years of age. The study is expected to enroll approximately 90 subjects at up to 5 study sites and is scheduled to conclude in the second quarter of 2013. Additional information on the Phase 2 study will be made available on ClinicalTrials.gov.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products, including products for the treatment of ADHD. The company is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. A stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., Noven serves as Hisamitsu's U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.