As part of its continued commitment to ADHD research, Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII).
Prospectively designed head-to-head clinical trials provide important information to physicians, patients, caregivers, and payors to make informed choices. There are no prospectively designed, randomized, double-blind, head-to-head clinical trials comparing the efficacy of these two frequently-prescribed medications for ADHD, making evidence-based treatment decisions a challenge.
"These studies are important to further our understanding of the possible differences in efficacy between Vyvanse and Concerta in treating adolescents with ADHD," said Jeffrey Jonas, MD, Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals and Regenerative Medicine businesses. "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."
Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
The two Phase 4 clinical trials are randomized, double-blind, multi-center, parallel-group, active-controlled studies. They are designed to explore differences in efficacy between Vyvanse and Concerta in adolescents ages 13 to 17 with ADHD. This clinical trial program will utilize the clinician-administered ADHD-RS-IV Total Score to compare the efficacy of Vyvanse to Concerta. One trial will employ a dose optimization design and the other will employ a forced-dose titration schedule. Together the two trials will enroll approximately 1,000 patients, and results are expected by second half of 2013. Additional information about the clinical trial program will be available on ClinicalTrials.gov.
Shire recently completed a Phase 3, 8-week double blind, dose-optimized, placebo-controlled study of Vyvanse in the treatment of ADHD in children and adolescents in which Concerta was an active reference arm. Formal comparisons between Vyvanse and Concerta were not planned as part of that study. However, the data do suggest this as an area for further investigation. The data from this study have been presented previously at a major psychiatry meeting in late 2011.
"It is important for practicing physicians to have access to information on comparative efficacy of different approved medications when developing a personalized treatment approach for individuals with ADHD," said Jeffrey Newcorn, MD, Associate Professor of Psychiatry and Pediatrics, Mount Sinai School of Medicine. "I expect the data from these studies may aid prescribers in making individualized treatment decisions for their adolescent patients with ADHD."