New stimulant medication option on the horizon – a once-daily transdermal patch

Noven Pharmaceuticals has announced positive Phase III clinical study results for its once-daily transdermal methylphenidate system – a “patch” that is replaced on a daily basis – to be called MethyPatch®.

In a 4-week study involving children (ages 6 to 12 years) who met DSM-IV criteria for ADHD, children received either MethyPatch or a placebo transdermal patch once-daily to the hip area, worn for 12 hours per day. (Six MethyPatch dosages were available for titration.) Efficacy of the patch was measured by teacher report using the “Inattention/Overactivity with Aggression” (IOWA) Conners. Parent and clinician report of improved behavior was considered as a secondary measure.

Compared with placebo, MethyPatch resulted in significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention. Reported side effects included reduced appetite, insomnia, abdominal pain and headache. Parents reported positive behavior changes and liked the control the patch offered because it could be removed at will by the parent. (A potential problem not mentioned by Noven is that children, of course, can also remove this patch at will.) All presently approved ADHD medications are delivered orally and therefore don’t offer this option.

No adult studies are reported as pending, however, like other stimulant medications, there is no reason to anticipate a different response among adults.