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Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD
Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients on Schedule for 3Q
About this update from Cingulate Inc.
[{"type":"text","content":"Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients on Schedule for 3Q 2023 Initiation KANSAS CITY, Kan., June 08, 2023 (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, today announced it has completed its Phase 3 adult dose-optimization trial of its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA). The Phase 3 CTx-1301-022 study (NCT05631626) assessed the onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. Results from the trial are expected in 3Q 2023 and will be submitted for presentation at a future medical meeting. “Currently available stimulant medications have failed to address the large and growing unmet need for true once-daily dosing in ADHD treatment, and onset and duration are two of the most important efficacy parameters that Cingulate plans to improve upon to achieve this,” said Raul R. Silva, M.D., Chief Science Officer, Cingulate. “If the Phase 3 CTx-1301-022 study results are positive, these data will add to the growing body of evidence from earlier trials showing that CTx-1301 has the potential to offer patients best-in-class onset and duration.” The United States Centers for Disease Control (CDC) has cited a 10 percent increase in stimulant medicine prescriptions in the adult ADHD population. Of the multitude of ADHD medications available, no methylphenidate medication offers a single oral dose that provides patients entire active-day efficacy. “Stimulant medications are the most effective tools we have to address ADHD symptoms in patients, but their short half-life require that more than 60 percent of patients be prescribed booster doses – a primary source of non-compliance and misuse of this class of medicines,” said Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator in the Phase 3 CTx-1301-022 study. “Ci...