FDA has sanctioned Shire’s Vyvanse® Capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents between 13 and 17. The approval is based on study data demonstrating that the drug improved symptoms compared to placebo.
Vyvanse was initially introduced in the U.S. in July 2007 for the treatment of ADHD in children ages 6 to 12. It was then approved in April 2008 to treat adults. In 2009, the drug made $505 million in sales, up 58% from 2008. In the first three quarters of this year, Vyvanse brought in $453.6 million, a 26% increase from the same period in 2008.
The randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study was conducted in 314 adolescents in this age group. They received one of three Vyvanse doses (30, 50, and 70 mg/day) or a placebo for four weeks. All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment.
The primary efficacy outcome was change in total score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). All Vyvanse dose groups were superior to placebo in the primary efficacy outcome, according to Shire.
The most frequently occurring treatment-emergent adverse events (greater than or equal to 5% and twice placebo) reported in patients treated with Vyvanse were decreased appetite, insomnia, and weight decrease. Safety results were generally consistent with previous Vyvanse studies in children and adults.
Shire is also studying Vyvanse as a combination treatment for ADHD in Phase III, as an adjunctive therapy for depression, to treat cognitive impairment in depression, and for negative symptoms and cognitive impairment in schizophrenia in three separate Phase II studies.
In the third quarter of this year, Shire ended its co-promotion agreement for Vyvanse with GSK. No termination fee or other payments were made or are due to GSK since agreed-upon sales thresholds were not achieved, according to Shire. GSK has, however, filed a lawsuit against Shire in the Philadelphia Court of Common Pleas seeking compensation.