Cingulate Reports Positive Results from 50mg CTx-1301 Fed/Fast ADHD Study

Cingulate Inc., a biopharmaceutical company based in Kansas City, has announced promising top-line results from a pivotal study of CTx-1301, a next-generation ADHD medication. This trial is part of the FDA's requirements to evaluate the impact of food on the absorption of the drug's highest dosage, 50 mg. CTx-1301 is an investigational, extended-release tablet formulation of dexmethylphenidate, known for its approval by the U.S. Food and Drug Administration for ADHD treatment.

The trial's findings underscore that 50 mg of CTx-1301 can be administered with or without food, an important attribute for patients' convenience. Pharmacokinetic measurements demonstrated consistent results, aligning with earlier studies, and confirmed a favorable tolerability profile for the medication. Shane J. Schaffer, PharmD, Chairman and CEO of Cingulate, emphasized that CTx-1301 is poised to be the first true once-daily stimulant medication capable of addressing ADHD symptoms throughout an entire active day. To achieve optimal patient care, the drug is offered in eight dosage strengths, allowing healthcare providers to tailor treatment to individual needs regardless of whether it is taken with food.

The CTx-1301-013 study involved 27 healthy adults, aged 18 to 50, who participated in a randomized sequence to receive a single 50 mg dose of CTx-1301 both with a standard high-fat breakfast and on an empty stomach. Blood samples were collected frequently over a 28-hour period to determine the absorption and elimination profile of dexmethylphenidate, providing detailed pharmacokinetic data.

Primary endpoints of the study included assessing the maximum plasma concentration (Cmax) and the total extent of dexmethylphenidate absorption, expressed as the area under the plasma drug concentration vs. time curve (AUC). These parameters are crucial for regulatory approval, offering insights into the drug's exposure levels.

Raul Silva, MD, Chief Science Officer at Cingulate, highlighted that CTx-1301 maintains its bioavailability regardless of food intake, a critical consideration for consistent treatment efficacy. The study's outcomes provide valuable clinical insights for healthcare professionals managing ADHD patients. Comprehensive results, including secondary endpoints such as half-life and onset time, are set to be presented at an upcoming medical conference.

ADHD is a chronic neurobiological disorder affecting millions of children and adults worldwide, characterized by symptoms of inattention and hyperactivity-impulsivity. In the United States alone, over 20 million individuals have been diagnosed with ADHD, with a significant percentage of children and adolescents continuing to exhibit symptoms into adulthood. The adult ADHD population is growing rapidly, surpassing the child and adolescent segments combined.

CTx-1301, Cingulate's flagship product, leverages the company's proprietary Precision Timed Release (PTR) platform to deliver a breakthrough formulation of dexmethylphenidate. This stimulant medication enhances norepinephrine and dopamine activity in the brain to improve attention and behavior. While stimulants remain the gold standard for ADHD treatment due to their effectiveness, it has been challenging to provide patients with all-day symptom relief. CTx-1301 addresses this issue by precisely timing three releases of medication throughout the day, covering periods when other extended-release products may lose efficacy.

Cingulate's PTR technology is designed to achieve true once-daily dosing by incorporating an Erosion Barrier Layer (EBL) that controls drug release at precise intervals. This innovative approach is intended to enhance treatment outcomes for ADHD and other therapeutic areas, such as anxiety disorders, where multiple daily doses are necessary for optimal results. Cingulate is actively exploring new applications for its PTR technology in additional therapeutic areas, aiming to expand its pipeline of next-generation pharmaceutical products.