FDA Approves Cingulate to Seek Marketing for CTx-1301 ADHD Treatment

May 21, 2024 – Cingulate Inc., a biopharmaceutical company known for its Precision Timed Release™ (PTR™) drug delivery platform, has announced significant progress in the development of its lead Phase 3 candidate, CTx-1301 (dexmethylphenidate), aimed at treating Attention Deficit Hyperactivity Disorder (ADHD) in individuals aged six and older. The U.S. Food and Drug Administration (FDA) has confirmed the requirements needed for the submission of a New Drug Application (NDA) for CTx-1301.

Key points from the FDA's communication to Cingulate include:
1. Following the 505(b)(2) pathway, the NDA submission for CTx-1301 does not necessitate continuation of the fixed dose and onset/duration studies.
2. Data gathered so far from these Phase 3 studies will be sufficient for the NDA filing.
3. Alongside NDA preparation, Cingulate will conduct a Phase 1 fed/fast study, expected to last two to three weeks, and include the results in the NDA.

Cingulate's Chairman and CEO, Shane J. Schaffer, emphasized the positive reception of the FDA’s guidance, noting that it provides a clear trajectory for timely NDA filing. This clarity enhances Cingulate’s discussions with potential partners for outlicensing CTx-1301 in the U.S. and internationally. Schaffer also highlighted the importance of engaging with key payer stakeholders to maximize access and market penetration, ultimately benefiting ADHD patients and their families.

Dr. Ann Childress, President of the Center for Psychiatry and Behavior Medicine, Inc., and the lead investigator for Cingulate's CTx-1301 onset and duration study, praised the treatment effect size of CTx-1301, comparing it favorably to current market offerings. Childress noted that many patients require additional, immediate-release doses to extend the efficacy of their medication throughout the day. Patients participating in the study expressed a desire to continue on CTx-1301 after the trial, indicating strong potential benefits for over 60 percent of ADHD patients currently reliant on booster doses.

Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025. Earlier this year, Cingulate presented data from the Phase 3 adult efficacy and safety study of CTx-1301 at the 2024 American Professional Society of ADHD and Related Disorders (APSARD) conference, where the findings underscored CTx-1301’s significant treatment effect.

Attention Deficit Hyperactivity Disorder (ADHD) is a chronic neurobiological and developmental disorder impacting millions of children and often extending into adulthood. In the U.S., approximately 11 percent of children under 18 have been diagnosed with ADHD, and about 80 percent of them receive treatment. Among adults, around 11 million individuals are estimated to have ADHD, though only 20 percent receive treatment.

CTx-1301, Cingulate’s lead candidate, leverages its proprietary PTR platform to create a multi-core formulation of dexmethylphenidate, a stimulant that enhances norepinephrine and dopamine activity in the brain, crucial for attention and behavior regulation. The PTR platform allows for precise, timed release of medication, ensuring a rapid onset and sustained efficacy throughout the day in a single tablet. This innovation could address the common challenge of maintaining an active-day duration of action for ADHD medications.

Cingulate's PTR technology, licensed from BDD Pharma, employs an Erosion Barrier Layer (EBL) that controls drug release at predefined times, avoiding premature release. This tablet-in-tablet formulation ensures the controlled erosion of the barrier layer until the drug is released. Cingulate aims to expand this technology beyond ADHD, exploring applications in anxiety disorders and other therapeutic areas requiring precise, multiple daily doses.

Cingulate Inc., headquartered in Kansas City, continues to advance its pipeline of next-generation pharmaceuticals designed to improve patient care for conditions with challenging daily dosing requirements and inadequate treatment outcomes.

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