Shire withdraws application for ADHD drug

Shire has withdrawn its European marketing authorisation application for a drug aimed to treat attention deficit hyperactivity disorder (ADHD).

The resolution to extract the submission of Daytrana (methylphenidate transdermal system) follows a request from regulators to conduct an additional clinical study.

Recently, plans to acquire the worldwide rights to Equasym IR and XL for treating ADHD were announced – and the company stated this has also affected the choice.

Upon completion of the transaction ? which is expected to be in the second quarter of 2009 – these two drugs will provide the firm with an entry to the European market for the condition.

Equasym IR is currently approved and marketed for ADHD in children aged six and over in the UK, Ireland, Denmark, Finland, Germany, Netherlands, Norway and Sweden.

The business concluded it “remains committed to providing a variety of medicines for the treatment of ADHD to benefit ADHD patients and their families around the world”.

In other news, Shire has filed a lawsuit against Barr Laboratories for alleged infringement of three of the former’s patents.