Cingulate Inc. announced that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.Details from the FDA communication to Cingulate include the following: Per the 505(b)(2) pathway, submission of CTx-1301?s NDA does not require continuation of the fixed dose study and the onset and duration study; Data collected to date from these two Phase 3 studies will be included in the filing; and Contemporaneously with the preparation of the NDA filing, Cingulate will conduct a Phase 1 fed/fast study, the study is expected to last approximately two to three weeks, with the results being included in the NDA filing. Cingulate has begun NDA preparation and expects to submit its filing in the first half of 2025. Earlier this year, Cingulate presented results 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 in Orlando, FL.

The results were previously presented at the 2023 Psych Congress, where a poster describing the data was selected as a finalist for the Psych Congress?s First Annual Poster Awards. The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301?s ADHD leading effect size. Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials.

ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11%) aged under the age of 18 have been diagnosed with ADHD.

Among this group, approximately 80% receive treatment, with 65-90% demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4%), almost double the size of the child and adolescent segment combined. However, only an estimated 20% receive treatment.

Cingulate?s lead candidate, CTx-1301, utilizes Cingulate?s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action.

CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate?s innovative PTR drug delivery platform technology.

It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet.

The EBL formulation, Oralogik?, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.