Shire plc (SHPGY) to Initiate Two Phase 4s for Vyvanse Caps vs. Concerta
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Shire plc (Nasdaq: SHPGY), 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.
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.
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.
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.
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