Cingulate Reaches Key Milestone in CTx-1301 ADHD Drug Manufacturing for FDA Clearance

June 25, 2024 -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, announced a significant milestone in its journey to bring a new ADHD treatment to market. The company has successfully completed the manufacturing of twelve registration batches for its key product, CTx-1301 (dexmethylphenidate), which is targeted at treating Attention Deficit Hyperactivity Disorder (ADHD). This achievement aligns with the requirements set by the U.S. Food and Drug Administration (FDA) for a new drug application (NDA).

Registration batches are a crucial step mandated by the FDA before a company can submit an NDA. These batches must be produced using the exact equipment, dosage strengths, and procedures intended for commercialization. Laurie Myers, Chief Operating Officer of Cingulate, emphasized the importance of this milestone, noting that it brings the company closer to meeting FDA guidelines and demonstrates a reliable manufacturing process and acceptable shelf life for CTx-1301.

Cingulate is now preparing its NDA submission, with plans to file it in the first half of 2025. The company recently confirmed with the FDA the necessary requirements for this process, ensuring a clear path forward.

ADHD is a chronic condition affecting millions of children and adults in the U.S. It is characterized by persistent inattention and/or hyperactivity-impulsivity, impacting daily functioning and development. In the U.S., approximately 6.4 million children and adolescents have been diagnosed with ADHD, with about 80 percent receiving treatment. Of those treated, 65-90 percent continue to exhibit symptoms into adulthood. The prevalence of adult ADHD is estimated at around 11 million individuals, although only 20 percent are currently being treated.

CTx-1301 leverages Cingulate’s proprietary Precision Timed Release (PTR) drug delivery platform to optimize the administration of dexmethylphenidate, a stimulant approved by the FDA for ADHD treatment. Stimulants are considered the gold standard for ADHD due to their effectiveness and safety. However, a common challenge is maintaining efficacy throughout the entire active day. CTx-1301 addresses this by delivering three precisely timed doses in a single tablet, ensuring rapid onset and sustained efficacy throughout the day. This method aims to provide continuous symptom control, especially when other extended-release stimulants begin to lose their effect.

In addition to ADHD, Cingulate is developing treatments for anxiety disorders using its innovative PTR drug delivery platform. The platform includes a proprietary Erosion Barrier Layer (EBL) that controls drug release at specific times without premature release. The EBL formulation, known as Oralogik™, is licensed from BDD Pharma. This technology allows for a tablet-in-tablet dose form, where the outer layer erodes at a controlled rate, eventually releasing the drug from the core.

Cingulate aims to expand its clinical-stage pipeline by developing additional product candidates in various therapeutic areas. The PTR technology is particularly suited for conditions requiring multiple daily doses at predefined intervals, offering significant improvements over existing treatments. 

Cingulate Inc. is dedicated to advancing its PTR platform to create next-generation pharmaceuticals that enhance patient outcomes, particularly for conditions requiring complex dosing regimens. Starting with ADHD, the company is exploring other therapeutic areas to broaden its impact and provide better treatment solutions.

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