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news.Cingulate, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead asset, CTx-1301 (dexmethylphenidate HCl), aimed at treating Attention Deficit/Hyperactivity Disorder (ADHD).
ADHD is characterised by inattention and/or hyperactivity-impulsivity that interferes with functioning or development. Credit: Marisa Howenstine on Unsplash.
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CTx-1301 is an extended-release tablet formulation designed for fast onset, all-day efficacy, and a smooth pharmacokinetic profile with a single dose.
Cingulate anticipates learning whether the NDA has been accepted for review by the FDA within 60 days of its 31 July submission.
Cingulate Chief Medical Officer Matthew Brams said: “The submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development.
“We believe CTx-1301 addresses key limitations of existing therapies and has the potential to improve outcomes for patients across age groups.”
Cingulate chairman and CEO Shane J. Schaffer said: “With a differentiated profile supported by robust clinical data, we believe CTx-1301 has the potential to capture meaningful share in the $23bn US ADHD market, bringing us closer to delivering long-term value for our shareholders as we transition from a development-stage company to a commercial organisation.
“Just as important, this NDA submission represents the first regulatory application of our proprietary Precision Timed Release platform – an innovative and scalable technology we believe can provide significant pipeline value across multiple indications where unmet needs remain high.”
ADHD is a chronic neurobiological and developmental disorder affecting millions of children and adults.
In the US, over 20 million people have been diagnosed with ADHD, including 12 million adults and over eight million children under 17.
The condition is characterised by inattention and/or hyperactivity-impulsivity that interferes with functioning or development.
