Noven Announces Positive Phase 2 Results of
Investigational d-Amphetamine Transdermal System For ADHD

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from its Phase 2 clinical study evaluating d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no amphetamine-based transdermal treatment option available for ADHD.

The Phase 2 study was a randomized, double-blind, placebo-controlled, crossover, laboratory classroom study to evaluate the safety and efficacy of d-ATS compared to placebo in subjects 6 to 17 years of age. The 7-week study enrolled 110 patients. 

The primary outcome measure in the study was mean total SKAMP score for d-ATS compared to placebo. The SKAMP scale measures manifestations of ADHD symptoms using an independent observer (teacher) rating of the child's impairment in classroom behavior. The Phase 2 study achieved the primary endpoint with statistical significance, and no serious adverse events were reported. 

Joel S. Lippman, M.D., Noven’s Executive Vice President & Chief Medical Officer, said: “We are pleased with the results of our d-ATS Phase 2 study, and are preparing to advance the program into Phase 3 development.”

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and 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.

Contacts:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
corporateaffairs@noven.com
305-253-1916