Shire starts Vyvanse Phase IV trials

 Shire has initiated two Phase IV clinical trials to assess the efficacy of Vyvanse (lisdexamfetamine dimesylate) against Johnson & Johnson’s Concerta (methylphenidate HCl).

The head-to-head studies will include more than 1,000 patients and aim to explore the differences in effectiveness between the two to allow relevant stakeholders to make informed choices.

Dr Jeffrey Jonas, Senior Vice President of R&D at Shire, says the trials are “important to further our understanding” between the two products frequently prescribed for ADHD.

There are currently no trials that compare the efficacy of the two products. This, Shire says, makes evidence-based treatment decisions a challenge.

The two trials are randomised, double-blind, multi-centre, parallel-group, active-controlled studies. They will explore any differences in efficacy between the two in patients with ADHD aged between 13 to 17.

One trial will employ a dose optimisation design, and the other employ a forced-dose titration schedule. The results are expected in 2013.

“It is important for practicing physicians to have access to information on comparative efficacy of different approved medications when developing a personalised treatment approach for individuals with ADHD,” said Dr Jeffrey Newcorn, Associate Professor of Psychiatry and Paediatrics, Mount Sinai School of Medicine. “I expect the data from these studies may aid prescribers in making individualised treatment decisions for their adolescent patients with ADHD.”

Vyvanse was approved for use in the US in July 2007 for the treatment of children with ADHD aged 6 to 12. In April 2008 it was approved for use in adults, and in November 2010 for adolescents aged between 13 and 17 with ADHD.