Catalent Pharma Solutions, headquartered in Somerset, N.J., has reached an exclusive development and licensing agreement with Cingulate Therapeutics (CTx), a Morristown, N.J.-based, privately held biopharmaceutical company, to support development of a series of new prescription pharmaceutical products for the treatment of attention deficit/hyperactivity disorder (ADHD) using Catalent's OSDrC OptiDose drug delivery platform.
The products, CTX-1301 and CTX-1302, currently are in preclinical development and are designed to overcome several long-standing unmet needs of patients diagnosed with ADHD. The company's lead product, CTX-1301, is expected to complete initial phase I/phase II human trials in early 2015. Cingulate Therapeutics primary focus is to develop and commercialize the CTx products in the U.S. subsequent to FDA review and approval, followed by the E.U. and other strategically important markets.
Catalent's OSDrC OptiDose is an innovative, flexible core tableting technology that enables the formulation and manufacturing of single or multi-cored tablets with differentiated controlled-release functionality and a range of unique dose forms, including fixed-dose combination tablets.
"OptiDose enables the design of dividable, multi-layer, single or multi-core tablets with a variety of core numbers, shapes, sizes and placement, providing new alternatives in controlled-release designs for drug formulators, developers and marketers in a high-quality, one-step manufacturing process," said Barry Littlejohns, president of Advanced Delivery Technologies for Catalent.