UK drugmaker Shire Pharmaceuticals says it expects the US Food and Drug Administration to come to a decision over the future of its attention-deficit hyperactivity disorder patch Daytrana by April 9.
Late last year US regulators issued the firm and its partner Noven with an approvable letter requesting more data on Daytrana (methylphenidate transdermal system) before full clearance can be given. Shire resubmitted this additional information on February 9, kicking off a 60-day final review period.
If the FDA approves the drug it will become the first skin patch formulation for the treatment of ADHD on the market, and is designed for once-daily in children aged six to 12 years. Shire has scheduled a launch during the first half this year if it gets the go-ahead.
Daytrana is one of six new products Shire is hoping to launch in 2006 to help it weather the loss of marketing exclusivity on oral ADHD treatment Adderall XR (mixed amphetamine salts), its top-selling drug. Adderall XR brought in third quarter sales of $166 million, but is facing generic challenges from a number of companies, including Barr and Impax.
Another patch-based treatment for ADHD, New River Pharmaceuticals' NRP104, was submitted for approval in the USA last month. Shire has co-promotion rights to this product in the USA, and exclusive rights elsewhere.