Cingulate (NASDAQ: CING) Receives FDA Clearance To Apply For New ADHD Drug Approval

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 "entire active-day efficacy" without the need for a booster dose. 

Cingulate Chairman and CEO Shane J. Schaffer expressed his gratitude for the FDA's guidance and perspective surrounding what he described as the company's "pathway to a timely NDA filing," adding: 

"We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the out licensing of CTx-1301 in the United States and abroad." 

With the hurdles to submitting its NDA application removed, Cingulate has set its sights on pursuing key partnerships for marketing its ADHD drug to patients and families who need it. 

ADHD is a neurological condition in which the brain, including surrounding nerves and neural networks, is affected owing to lower levels of dopamine and norepinephrine compared with a normally functioning brain. Close to 9 million American adults suffer from some form of ADHD, while as many as 6 million children under the age of 18 have been diagnosed with the condition. 

FDA's Message To Cingulate 

Cingulate's phase 3 study of CTx-1301 focused on adults diagnosed with ADHD, examining the safety and efficacy of the drug. More specifically, the study sought to recognize the onset and duration of the drug's effect. 

Thanks to the FDA's nod, Cingulate will no longer need to complete the fixed-dose study or the onset and duration studies. Instead, information already gathered from phase 3 studies should be included in the company's new drug application, including improvements in the severity of their illnesses that patients who received optimized doses of CTx-1301 showed vs. a placebo group.

As Cingulate prepares for its NDA, the FDA has requested that the company perform a several-week phase 1 fed/fast study, the results of which will be included in the NDA filing.  

Ann Childress, M.D., President at the Center for Psychiatry and Behavior Medicine as well as lead investigator of Cingulate's CTx-1301 onset and duration study, provided a key endorsement of the drug. The patients under her observation who were taking CTx-1301 were keen to stay on the medicine even after the trial was over. She stated: 

"If approved, I believe CTx-1301 could potentially benefit the more than 60% of patients currently using immediate-release booster doses to extend the efficacy of their medications."

Cingulate Pipeline 

In addition to CTx-1301, Cingulate has another product candidate, CTX-1302, which similarly serves the U.S. ADHD market. The company also has yet another drug in development, CTX-2103, which is being made to support the $3.2 billion U.S. anxiety market. 

All three of these therapies use the company's Precision Timed Release drug delivery platform technology and are intended to relieve patients of common unmet needs. Features include all-day duration and quick onset times upon taking the medication. They're all also made to eliminate the need for booster doses and minimization of crash symptoms as the medication loses its potency. 

Cingulate represents an exciting opportunity in the biotechnology space with several key catalysts in place. The latest FDA clearance is an indication of the promise in the company's treatment.

Featured photo by Louis Reed on Unsplash. 

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