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Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTx-2103 (buspirone)
KANSAS CITY, Kan., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed
About this update from Cingulate Inc.
[{"type":"text","content":"KANSAS CITY, Kan., Dec. 01, 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 that it has received guidance from the Food and Drug Administration (FDA) on advancing its investigational asset CTx-2103 (buspirone) for the treatment of anxiety into clinical development. “Cingulate received input from the FDA regarding the regulatory pathway for CTx-2103, including filing an Investigational New Drug (IND) application in the first half of 2024 and the design of clinical studies,” said Cingulate Chairman and CEO Shane J. Schaffer. “This is a positive step that may allow CTx-2103 to seek and win approval under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway.” Anxiety disorders are the most common mental health concern in the U.S.1 An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated.2 CTx-2103, which contains the active pharmaceutical ingredient buspirone hydrochloride, is a non-benzodiazepine medication that does not carry the risk of withdrawal or dependency. However, due to its short half-life, buspirone is prescribed to be taken several times a day for management of anxiety, which can be challenging for patients and may lead to sub-optimal treatment outcomes. CTx-2103 is a once-daily, multi-dose tablet that provides three precisely timed doses of buspirone versus one immediate release dose. The Company believes its trimodal tablet will offer clear differentiation and compelling advantages over currently available treatment options. In September 2022, Cingulate completed a formulation study in which the pharmacokinetics of CTx-2103 were evaluated. Additionally, scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which was correlated with the pharmacokinetic data to establish the release profile of the CTx-2103 formulation. Based on the data from this study, CTx-2103 provides three timed releases of buspirone, as it was designed to do. About CTx-2103 CTx-2103 is ...