Posted by Michael Wonder on 21 Jun 2017
Neos Therapeutics announces FDA approval of Cotempla XR-ODT (methylphenidate) extended release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old
19 June 2017 - First approved methylphenidate extended release orally disintegrating tablet for the treatment of ADHD.
Neos Therapeutics today announced that the U.S. FDA approved Cotempla XR-ODT, the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old.
The approval of Cotempla XR-ODT was supported by a Phase 3 clinical trial in children in a laboratory classroom setting. Treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day (placebo-subtracted difference of -11 [95% CI -13.9, -8.2]). Onset of effect was evident at one 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.i In addition, data from bioequivalence and pharmacokinetic studies in children with ADHD was also submitted.
