FDA approves Cotempla XR-ODT, (methylphenidate extended-release orally disintegrating tablet) to treat ADHD.- Neos Therapeutics

Neos Therapeutics, Inc. has announced that the 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. Neos is the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form.

The approval of Cotempla XR-ODT was supported by a Phase III 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 postdose 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. In addition, data from bioequivalence and pharmacokinetic studies in children with ADHD was also submitted.

Cotempla XR-ODT and Adzenys XR-ODT are Schedule II controlled substances. CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Physicians should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence.