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Cingulate Completes First Cohort of Phase 3 Adult Onset and Duration Trial of CTx-1301 (dexmethylphenidate) for ADHD
Trial On Track for 3Q 2023 Results Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023 KANSAS CITY, Kan., April 04, 2023 (GLOBE
About this update from Cingulate Inc.
[{"type":"text","content":"Trial On Track for 3Q 2023 Results Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023 KANSAS CITY, Kan., April 04, 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 the first cohort of its Phase 3 adult onset and duration trial of its lead candidate, CTx-1301 (dexmethylphenidate), for attention deficit/hyperactivity disorder (ADHD). The Phase 3 CTx-1301-022 study (NCT05631626) is assessing the onset and duration of CTx-1301 in up to 25 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. The study is comprised of a screening period, a five-week dose-optimization phase, a double-blind randomized phase, and a seven-day safety follow-up period. Results from the trial are expected in 3Q 2023. “We’re pleased with the speed in which our first cohort of this Phase 3 trial was able to be completed, underscoring the ADHD community’s interest in new stimulant treatment options and affirming our goal of having full trial results by third quarter 2023,” said Shane J Schaffer, Chairman and CEO, Cingulate. “There is a large and growing population of adults with ADHD who with appropriate diagnosis stand to benefit from effective entire active-day efficacy, and we’re confident that an optimized version of the already-established active ingredient in CTx-1301, dexmethylphenidate, could be an important addition to the $22 billion ADHD market.” 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 stimulant medication offers a single oral dose that provides patients entire active-day efficacy. “Our lead asset, CTx-1301, is being developed to provide a once-daily oral treatment that delivers a fast onset of action, an improved tolerability profile, and – importantly – entire active-day efficacy via our proprietary Precision Timed Release™ platform technology,” said Matthew Brams, MD, Chief Medical Officer, Cingulate. “Along with eight dosing strengths to best optimize patients unique dosing needs, the CTx-1301 cli...