Cingulate Inc. has announced promising safety results from its final Phase 3 trials for CTx-1301, a novel once-daily ADHD medication, setting the stage for a potential FDA submission in mid-2025. The comprehensive data package includes results from two pediatric and adolescent studies and a food effect study in healthy adults.
The safety findings, derived from multiple clinical trials involving both fixed-dose and dose optimization protocols, revealed no serious treatment emergent adverse events (TEAEs) across all study populations. The consistent safety profile has remained stable throughout nine clinical trials, marking a significant milestone in the drug's development journey.
Novel Drug Delivery Technology
CTx-1301 employs Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform, which enables three precise releases of dexmethylphenidate throughout the day from a single tablet. This innovative approach aims to provide sustained ADHD symptom control without the need for additional booster doses.
"While we have many approved stimulant medications at our disposal as clinicians, booster doses in the morning and/or afternoon are still needed," explained Dr. Ann C. Childress, recent president of the American Professional Society of ADHD and Related Disorders (APSARD). "These may lead to issues with adherence, efficacy, side effects such as crash and rebound, as well as the potential for abuse and diversion of these short-acting stimulant medications."
Clinical Trial Details
The Phase 3 program included:
- A dose optimization study in children aged 6-12 years, testing doses ranging from 6.26mg to 37.5mg
- A fixed-dose study in patients aged 6-17 years, evaluating doses of 18.75mg, 25mg, and 37.5mg
- A food effect study in healthy adults using a 50mg dose
Initial findings from the food effect study align with previous results, suggesting CTx-1301 can be taken with or without food, adding to its practical benefits for patients.
Addressing a Significant Market Need
ADHD affects approximately 6.4 million children and adolescents in the U.S., with 80% receiving treatment. The adult ADHD population is estimated at 11 million, though only 20% currently receive treatment. CTx-1301's once-daily dosing could potentially improve treatment adherence and outcomes across these populations.
"The safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials," said Shane J. Schaffer, Cingulate's Chairman and CEO. "We look forward to our in-person meeting with the FDA next month in preparation for the submission of our new drug application this summer."
Path to Approval
Cingulate has submitted the safety data ahead of an in-person Pre-NDA meeting with the FDA scheduled for April 2, 2025. The company plans to prepare a final analysis combining both adult and pediatric safety and efficacy data for inclusion in the NDA submission, anticipated for mid-2025.
