Cingulate Announces Pre-NDA Meeting With FDA For Discussion Of New Drug Application For Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., April 03, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

"Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025. We truly appreciate the FDA personnel who have been involved with the regulatory review of CTx-1301 to date. These interactions have been essential in helping us generate data to demonstrate the consistency and therapeutic benefit of our product. This important milestone is validation of our mission to bring to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day," said Cingulate Chairman and CEO Shane J Schaffer.

Last month Cingulate released Phase 3 safety data for CTx-1301, as well as the results from a food effect study with healthy adults, using a single 50-mg dose of CTx-1301, Cingulate's highest dosage. A review of the results found that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.