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Cingulate Presents Data for Its Triple-Release Buspirone Product Candidate: CTx-2103
Data Demonstrated Ability of CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone – Setting the Stage for Future Trials Employing
About this update from Cingulate Inc.
[{"type":"text","content":"Data Demonstrated Ability of CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone – Setting the Stage for Future Trials Employing Cingulate’s Precision Timed Release™ (PTR™) Technology CTx-2103 has the Potential to be the First Once-Daily Formulation of Buspirone, One of the Most Widely Prescribed Agents in $5.5B U.S. Anxiety Market KANSAS CITY, Kan., Sept. 19, 2022 (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 findings from its formulation study for CTx-2103, the Company’s asset for the management of anxiety-related disorders. The data was featured in a poster presentation at the 2022 Psych Congress meeting, taking place September 17-20 in New Orleans, LA. “The readout of the data is a crucial step in our quest to bring the best-possible, once-daily formulation of buspirone to patients,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “Formulation development is the key component in how we approach building next-generation medicines aimed at changing the paradigm of oral drug delivery. These results provide critical information as we move forward to designing our clinical program for anxiety.” In the study, the pharmacokinetics were evaluated for three multi-layered, timed-release oral tablets and one immediate release dose of buspirone. Scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. “Based on the dissolution profile seen in the data, the CTx-2103 30 mg tablet achieved the solubility required to deliver a triple release of buspirone hydrochloride,” said Matthew Brams, M.D., Chief Medical Officer and a Co-Founder of Cingulate. “The tablet was also able to deliver the intended doses at three time points. Based on this data, we’re confident in the ability of CTx-2103 to provide patients with the opportunity for entire-day efficacy, safety, and convenience in a once-daily anxiety medication.” Anxiety disorders are the most common mental health concern in the U.S.1 An estimated 31 per...