FDA approves Neos' Cotempla XR-ODT for ADHD

Last month, FDA approved an NDA from Neos Therapeutics Inc. (NASDAQ:NEOS) for Cotempla XR-ODT (methylphenidate XR-ODT) to treat ADHD in patients ages 6-17. The product is an extended-release oral disintegrating tablet formulation of methylphenidate using Neos' Rapidly Disintegrating Ionic Masking (RDIM) technology. Neos expects to launch the drug this fall.

In 2015, FDA issued a complete response letter for Cotempla XR-ODT requesting that Neos conduct a bridging study to demonstrate bioequivalence between clinical trial material and the commercial scale formulation of the product (see BioCentury, Nov. 23, 2015)...