Biopharmaceutical company Cingulate CING has been cleared by the U.S. FDA to pursue approval for its drug that treats Attention Deficit Hyperactivity Disorder (ADHD).
Cingulate reports that it is in alignment with the FDA on the requirements to file a New Drug Application (NDA) for the company's ADHD treatment, lead phase 3 candidate CTx-1301 (dexmethylphenidate) for patients who are at least six years old, and has received confirmation from the FDA to go ahead and file its application. The nuances between regulatory clearance and approval are worth noting. FDA approval indicates to a company that they have demonstrated that the benefits of a drug surpass the risks.
In response to this designation, drugmakers must apply for pre-market approval and offer clinical testing results to qualify for formal approval. By clearing Cingulate, the FDA is indicating that the burden of proof is on the company to show that its ADHD drug is "substantially equivalent" to similar therapies already available in the market, as those competing drugs set a predicate. The problem with current ADHD therapies, which use long-acting stimulant formulations of methylphenidate and amphetamine, is the prevalence of "crash and rebound scenarios.
.. occurring in late afternoon," as Cingulate explains in a recent assessment .
Cingulate's version of the drug harnesses what the company describes as "a tri-modal release of dexmethylphenidate (CTx-1301)" to accelerate the drug's activation, resulting in an "entir.
