Shire to compare Vyvanse to J&J’s Concerta in head-to-head studies

Shire will carry out two comparative studies of its attention-deficit hyperactivity disorder (ADHD) drug Vyvanse with rival product Concerta from Johnson & Johnson (J&J) in a bid to differentiate them in the marketplace.

Vyvanse (lisdexamfetamine dimesylate) growth has already been outpacing the overall market for ADHD drugs, with sales up 27 per cent in 2011 to $805m and a 17 per cent share of the US market.

However, the ADHD market is set for a major shake-up as a generic version of Concerta (methylphenidate hydrochloride) starts to gain market share, so Shire is trying to make a case for Vyvanse over its rivals.

Concerta sales came in at $1.28bn last year, down almost 6 per cent, with US sales down more than 11 per cent to $822m thanks to generic competition.

This was initially from an 'authorised generic' from Watson Pharmaceuticals which launched last May but other rivals are expected from 2014.

Shire says it is planning two phase IV studies to compare Vyvanse and Concerta in adolescents with ADHD aged 13 to 17 to "provide important information to physicians, patients, caregivers, and payers to make informed choices".

A recently completed phase III study, which included Concerta as a reference treatment provided some suggestions that Vyvanse was superior, although the company is quick to point out that no formal comparisons were part of the study.

The data did however suggest this would be an area "for further investigation", it added.

The phase IV trial programme will make use of the clinician-administered ADHD-RS-IV Total Score system to compare the efficacy of Vyvanse to Concerta, according to Shire.

One trial will employ a dose optimisation design and the other will employ a forced-dose titration schedule. Together the two trials will enrol about 1,000 patients, with results expected by the second half of 2013, potentially ahead of any additional generic competitors in the US.

The bulk of Vyvanse sales come from the US market. The product is currently under regulatory review in Europe, where it will be sold as Venvanse, with the UK is acting as the reference member state for this application.