Catalent Pharma Solutions has reached an exclusive development and licensing agreement with privately held biopharmaceutical company, Cingulate Therapeutics (CTx), to support the 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, are currently in pre-clinical 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 US subsequent to FDA review and approval, followed by the EU 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,” commented Barry Littlejohns, President of Advanced Delivery Technologies for Catalent. “We are excited to be working with Cingulate Therapeutics to bring these important treatments to market as quickly and efficiently as possible.”
“Cingulate Therapeutics is proud to partner with Catalent in developing these innovative therapies, designed to overcome longstanding unmet needs in ADHD,” added Shane Schaffer, Chairman and CEO of Cingulate Therapeutics. “After extensive evaluation of several drug delivery technologies, OptiDose was clearly identified as the leading platform technology to support our development strategy. The precision engineered, cutting-edge technology and strong patent protection inherent to OptiDose, coupled with Catalent’s unparalleled expertise in drug formulation, provides Cingulate Therapeutics great confidence in its overall ability to deliver safe, effective and innovative treatment options to clinicians and patients alike.”