There was good news for Shire Pharmaceuticals this week after regulators in Canada issued another green light for its attention-deficit hyperactivity disorder drug Vyvanse.
Health Canada has now approved Vyvanse (lisdexamfetamine dimesylate capsules) for treatment of the condition in adolescents (aged 13-17) and adults, following its 2009 clearance of the drug for children aged six to 12 years, and thereby significantly extending its potential market reach.
According to the company, Vyvanse, a follow-up to Shire's hugely successful ADHD drug Adderall XR, is the first and only once-daily prodrug stimulant approved to treat ADHD in adolescents and adults, with the latter group representing an important but often overlooked target population.
“There is a misconception that ADHD is a childhood condition but the reality is that an estimated 1.1 million Canadian adults, are living with this neurological condition, the symptoms of which can significantly impact all aspects of daily living,” noted ADHD expert Isaac Szpindel, welcoming the approval.
The drug won favour with regulators after Phase III clinical trials demonstrated its ability to significantly improve scores on the ADHD Rating Scale, which measures the core symptoms of the disease - inattention, hyperactivity and impulsivity - compared to placebo.