Shire and Noven have reported positive preliminary data from clinical trials of a patch that they are developing for children with attention deficit hyperactivity disorder.
The two studies, a Phase II trial involving 79 patients over a seven week period and a Phase III study involving 268 patients over a seven week period, examined the product – known as methylphenidate transdermal system – in children between the ages of six and 12 previously diagnosed with ADHD. Overall, MTS was well tolerated and both trials met their objectives, the firms said. Additional information will be revealed as part of Shire’s research and development update, which is scheduled to take place next month.
The firms said that the data would be included in as part of an amendment to the New Drug Application for the product, which was filed with the US Food and Drug Administration back in 2002 but knocked back the following year [[29/04/03b]]. Both Shire and Noven believe that the studies will address issues raised by the FDA, and note that the agency has previously confirmed that the amendment will be reviewed within six months after submission.
Shire acquired the worldwide sales and marketing rights to MTS from Noven in February 2003 [[28/02/03b]]. Should it win final approval, the patch is expected to be a strong contender in the increasingly competition ADHD marketplace. The firms hope it will offer an alternative to traditional pills, especially for children that have difficulty taking oral medications. Shire already boasts a strong position in the ADHD market with its flagship drug, Adderall XR (extended-release amphetamine salts). However, safety concerns arose earlier this year after the Canadian regulators pulled the plug on the drug following concerns that it had been linked to cases of sudden death [[10/02/05a]].