Cingulate (CING) submitted its New Drug Application to the U.S. Food and Drug Administration for CTx-1301, the company’s lead asset for the treatment of Attention Deficit/Hyperactivity Disorder. CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. Cingulate may learn if the NDA has been accepted for review by the FDA within 60 days of its July 31 submission.
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