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Formulation will utilize Catalent?s OSDrC OptiDose multicore drug-delivery platform.
Catalent Pharma Solutions has entered into an exclusive development and licensing agreement with biopharmaceutical company, Cingulate Therapeutics, to support the development of new formulations for the treatment of attention deficit/hyperactivity disorder (ADHD) using Catalent’s OSDrC OptiDose drug-delivery platform.
Cingulate Therapeutics products—CTX-1301 and CTX-1302—to address several unmet needs of patients with ADHD are currently in the preclinical development stage. CTX-1301, the company’s lead product, is expected to completed initial Phase I/II evaluation in early 2015.
Cingulate Therapeutics primary focus is to develop and commercialize the CTx products in the US subsequent to FDA review and approval, followed by the EU and other strategically important markets.
Catalent’s OSDrC OptiDose is a flexible core tableting technology that enables the formulation and manufacturing of single or multicored tablets with differentiated controlled-release functionality and a range of unique dose forms, including fixed dose combination tablets.