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Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In
About this update from Cingulate Inc.
[{"type":"text","content":"Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug Administration (FDA) requirements, 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 today that it has completed the manufacturing of its twelve registration batches for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Registration batches are required by the U.S. Food and Drug Administration (FDA) to be manufactured before submitting a new drug application (NDA) using the actual equipment, dosage strengths and procedures that will be used to commercialize the drug product candidate. “This achievement brings us one step closer to compliance with the FDA’s guidance for submission of an NDA, and is an important chemical, manufacturing and control (CMC) inflection point for CTx-1301, as these pivotal batches are used to demonstrate that we have a reliable manufacturing process and acceptable shelf life for our product,” said Cingulate Chief Operating Officer Laurie Myers. Cingulate, which recently announced it had received confirmation from and agrees with the FDA on the requirements necessary for filing an NDA for CTx-1301, has begun NDA preparation and expects to submit its application in the first half of 2025. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined. However, only an estimated 20 percent r...