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Cingulate Announces Detailed Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD
CTx-1301 Demonstrated Clinically Meaningful Improvements in Permanent Product Measure of Performance (PERMP) and Clinical Global Impression Scale (CGI-S)
About this update from Cingulate Inc.
[{"type":"text","content":"CTx-1301 Demonstrated Clinically Meaningful Improvements in Permanent Product Measure of Performance (PERMP) and Clinical Global Impression Scale (CGI-S) Scores, with Investigators Observing Trend Toward Significance Treatment Effect Size of 1.41 and 0.98 Observed at 30 Minutes and at Hour 16, Respectively; Currently Available Long-Acting Stimulants Range from 0.5 to 0.91 CTx-1301 Demonstrated a Favorable Safety Profile in the Trial Compared to Placebo KANSAS CITY, Kan., Sept. 11, 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, announced full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards. The Phase 3 CTx-1301-022 study (NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. The data from the trial, presented at the 2023 Psych Congress, did not achieve statistical significance on the primary efficacy endpoint but demonstrated a trend toward significance in improving Permanent Product Measure of Performance (PERMP) scores with CTx-1301 compared to placebo. Clinical Global Impression Scale [CGI-S]) scores with CTx-1301 compared to placebo also showed significant improvements even though the study was not powered for statistical significance. “Even with currently available extended-release formulations of dexmethylphenidate, many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. CTx-1301 is designed to release dexmethylphenidate multiple times throughout the day in just one tablet, with the last release happening around the time that plasma concentrations of other stimulants start to wane,” said Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc. and lead investigator. “The trea...