Shire is initiating two Phase 4 clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta (methylphenidate HCl) Extended-Release Tablets, (CII) in the treatment of adolescents with attention-deficit/hyperactivity disorder (ADHD).
The prospectively designed, head-to-head clinical trials will provide important information to physicians, patients, caregivers, and payors to make informed choices, said the company.
Shire Specialty Pharmaceuticals and Regenerative Medicine businesses MD and senior vice president of Research and Development Jeffrey Jonas said the studies are important to further the company’s understanding of the possible differences in efficacy between Vyvanse and Concerta in treating adolescents with ADHD.
"Shire’s investment in this innovative program underscores our commitment to improving patient care by providing prescribers with additional information on which to base treatment decisions," Jonas said.
The two Phase 4 clinical trials are randomized, double-blind, multi-center, parallel-group, active-controlled studies, and are designed to explore differences in efficacy between Vyvanse and Concerta in adolescents ages 13 to 17 with ADHD.
As part of the trial program, the clinician-administered ADHD-RS-IV total score will be utilized to compare the efficacy of Vyvanse to Concerta.
The two trials will enroll approximately 1,000 patients; one trial will employ a dose optimization design and the other will employ a forced-dose titration schedule.
Shire said the results are expected by second half of 2013.