The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.
The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.
Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.
Find the full press release on Neos Therapeutics website.