The once-daily treatment is an oral formulation of central nervous system stimulant methylphenidate.
The US Food and Drug Administration (FDA) has approved Cotempla XR-ODT (methylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD).
Cotempla XR-ODT, by specialty pharmaceutical company Neos Therapeutics, is an orally disintegrating tablet (ODT) formulation of central nervous system stimulant methylphenidate. It was tested and intended for once-daily, extended-release ADHD treatment in children.
Methylphenidate has been prominent in treatment for attention-deficit disorder (ADD) and narcolepsy.
Neos originally submitted a New Drug Application (NDA) to the FDA for Cotempla XR-ODT in January 2015, following a successful Phase III clinical trial. The multicenter, randomized, double-blind, placebo-controlled laboratory classroom study compared treatment versus placebo in ADHD children patients aged 6-12 years old.
Versus placebo, the treatment met all primary and secondary efficacy endpoints and showed statistically significant improvements in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Scale and Permanent Product Measure of Performance (PERMP) Scale.
However, the FDA Center for Drug Evaluation and Research submitted a Complete Response Letter to Neos in November 2015, requiring a bridging study to demonstrate bioequivalence between the clinical trial material and the potentially marketed drug. They also required an assessment of food effect, provided validation, and 3 months’ worth of stability data.
Neos submitted the requested information in the following month.