US FDA approves Adderall XR to treat adults

Published: 12-Aug-2004

Adderall XR, Shire Pharmaceuticals' treatment for Attention Deficit Hyperactivity Disorder (ADHD), has been approved by the US FDA as a once-daily treatment for adults.


Adderall XR, Shire Pharmaceuticals' treatment for Attention Deficit Hyperactivity Disorder (ADHD), has been approved by the US FDA as a once-daily treatment for adults.

Shire will begin promoting the adult indication in the US immediately. In addition, the FDA has confirmed to Shire that new 40mg, 50mg and 60mg dose strengths of Adderall XR will require additional clinical data for approval.

'The impact of ADHD on people's ability to carry out their daily lives and work effectively is being increasingly acknowledged and the market for adult patients could ultimately be double that for pediatric patients,' said Shire ceo Matthew Emmens. 'Although we have not been able to promote adult usage, many physicians have been prescribing Adderall XR for adults 'off label' for some time. Adults represent 15-20% of the current Adderall XR total prescriptions.'

An estimated 4.4% of the US adult population is affected by ADHD. Adderall XR net sales for the six months to June 2004 were US$283m, 30% up on the same period in 2003.

  

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