US regulators have approved the use of Shire’s attention-deficit hyperactivity disorder drug Vyvanse in adolescents aged 13-17 years, adding to its prior indications for children aged six to 12 years and adults.
The US Food and Drug Administration’s green light for this particular patient population came on the back of strong data from a randomised, double-blind, placebo-controlled, forced-dose escalation study, in which adolescents were given either a 30, 50 or 70mg/day dose of Vyvanse (lisdexamfetamine dimesylate) or a placebo.
According to the firm, the results showed that, after four weeks of treatment, all Vyvanse dose groups were superior to placebo in showing an improvement on the ADHD Rating Scale, which measures the core symptoms of the disease - inattention, hyperactivity and impulsivity.
In addition, the trial also showed that the side effects of Vyvanse, which is a federally controlled substance because of its potential for dependency and abuse, were consistent with those observed in previous studies, further cementing its safety profile.
“This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms,” said Mike Yasick, Senior Vice President of Shire’s ADHD Business, commenting on the approval.
A follow-up to the firm’s hugely successful ADHD drug Adderall XR,Vyvanse was first launched in the US in 2007 for the treatment of children with the condition. The drug pulled in sales of $151 million during the last quarter, and its performance will undoubtedly receive a boost from the newly-expanded target population.