Encouraging data for methylphenidate patch
Positive clinical trial data for methylphenidate transdermal system (MTS) to treat attention deficit/hyperactivity disorder in children were released by Shire
Pharmaceuticals this week.
The results from two randomised controlled trials were reported — a
phase II study involving 80 children and a phase III study involving
268 children.
The first trial involved a five-week open-label dose optimisation period
followed by a two-week crossover period with placebo. The results showed
that measurements of performance and behaviour were significantly better
in the MTS group than the placebo group (P<0.0001). This difference
was apparent two hours after application of the patch and was maintained
for 12 hours. The safety profile for the patches was similar to that
reported for approved methylphenidate products.
The second study was of a similar design but, in addition, it compared
MTS with oral methylphenidate (Concerta XL). Children in the MTS and
Concerta groups showed significant improvements in performance and behaviour
compared with those in the placebo groups after two weeks of optimal
dosing (P<0.0001). Again, the safety profile of MTS was similar to
that of oral methylphenidate. |
The
Pharmaceutical Journal
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