In 2 recent clinical trials, a treatment for young patients diagnosed with attention deficit hyperactivity disorder reportedly demonstrated benefit over another currently used ADHD medication.
In 2 recent clinical trials, a treatment for young patients diagnosed with attention deficit hyperactivity disorder (ADHD) reportedly demonstrated benefit over another currently used ADHD medication.
In a pair of phase 4 efficacy and safety studies, Vyvanse (lisdexamfetamine dimesylate) was deemed “statistically superior” to Concerta (methylphenidate HCl) on primary analysis with “mean reductions on the ADHD Rating Scale-IV (RS-IV) total score of 25.4 and 22.1 points, respectively,” according to a statement from drugmaker Shire PLC.
The first forced-dose titration study with a placebo reference arm was designed to examine the efficacy and safety of the drug in patients aged between 13-17 years. In the study, patients were randomized to receive 70 mg of Vyvanse, 72 mg of Concerta, or placebo on a daily basis for 6 weeks, followed by a 1-week safety follow-up.
According to Shire, the baseline ADHD-RS-IV total scores were 37.3, 37.0, and 36.1 for Vyvyanse, Concerta, and placebo, respectively. At the conclusion of the study, the
Vyvanse patients experienced an average 25.4-point reduction in their measures, while Concerta patients saw a 22.1-point drop, and the placebo group dropped only 17 points.
One patient from each group experienced a serious adverse event (SAE), while 16 Vyvanse, 15 Concerta, and one placebo patient had a treatment-emergent adverse event (TEAE) that required withdrawal from the study. Those taking Vyvanse reported decreased appetite, headache, insomnia, dry mouth, and dizziness, and those taking Concerta reported many of the same symptoms.
The second dose-optimization study with a placebo reference arm compared Vyvanse to Concerta in adolescents with ADHD. The outcome of the study was based on changes from baseline measures at week 8, followed by a 1-week safety follow-up period.
At the end of the dose-optimization period, 8.2% of patients received 30 mg doses of Vyvanse, while 27.2% received 50 mg doses and 52.2% received 72 mg doses. For Concerta, 5.4% were taking 18 mg, 18.5% were taking 36 mg, 22.3% were taking 54 mg, and 46.2% were taking 72 mg. The baseline scores were 36.6 for Vyvanse, 37.8 for Concerta, and 38.2 for placebo, but by the end of the study, those scores were reduced by 25.6, 23.5, and 13.4 points, respectively.
Again, one patient from each medication group suffered an SAE, while 14 Vyvanse patients, 3 Concerta patients, and 3 placebo patients had TEAEs that caused them to drop out of the study. The patients reported many of the same TEAEs seen in the first study, as well as nasopharygitis and somnolence.
Phil Vickers, Global Head of Research and Development for Shire, said the new results for Vyvanse are promising.
“Treatment decisions for adolescents are complex, as they are in a state of transition into adulthood, and they experience greater challenges in school, home, and social settings,” Vickers said. “Prospectively designed head-to-head clinical trials provide important information to physicians, patients, caregivers, and payers to make informed decisions.”
Despite the positive results, the study authors said further evaluations on the efficacy and safety of Vyvanse are needed .