Neos Therapeutics Inc. completed the resubmission of a new drug application to the U.S. FDA for Cotempla XR-ODT, a treatment for attention deficit hyperactivity disorder.
The drug is a methylphenidate extended-release orally disintegrating tablet and is the third ADHD-related product of the company.
In November 2015, Neos received an FDA-issued complete response letter for the drug requiring the company to conduct a bridging study to show bioequivalence between the clinical trial material and the to-be-marketed drug product, including an assessment of food effect, and to provide validation and three months of stability data.
The class 2 resubmission follows the successful completion of the bioequivalence bridging study and the validation and stability campaigns, and has a target six-month review period. Neos' application includes data from a phase 3 clinical efficacy and safety study in children in a laboratory classroom setting, which showed a statistically significant improvement in ADHD symptom control compared to placebo.
If the application is approved, Neos Therapeutics expect to sell Cotempla along with recently submitted NT-0201 and Adzenys XR-ODT by the end of 2017, President and CEO Vipin Garg said in a statement.