US-based Cingulate has plans to submit a new drug application with the US Food and Drug Administration (FDA) for the CTx-1301 (dexmethylphenidate) once-daily stimulant by mid-2024.

To be submitted under the Section 505(b)(2) pathway, the application will be based on the expected positive results from three Phase III studies in adult, paediatric, and adolescent populations.

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Cingulate CEO Shane J Schaffer said: “This Phase III trial is a major validation of what Cingulate has set out to accomplish: create the only ADHD medication that overcomes the major unmet needs of available treatments with clear and unmatched differentiation.

“We believe that the analysis of the full data set from this trial, along with completing our two upcoming trials in paediatric and adolescent patients, will allow us to submit a new drug application for CTx-1301 by mid-2024, and most importantly, provide patients, physicians, and payors a product that can provide exceptional ADHD treatment.”

Today, Cingulate has released top-line results in the adult population and is planning to initiate two Phase III trials of CTx-1301 for treating attention-deficit/hyperactivity disorder (ADHD) in paediatric and adolescent patient populations in August 2023.

CTx-1301 is a stimulant drug that uses Cingulate’s Precision Timed Release (PTR) drug delivery platform technology to time three releases of dexmethylphenidate, an FDA-approved compound, throughout the day. This increases norepinephrine and dopamine activity in the brain to treat ADHD.

In the single-centre, placebo-controlled, randomised Phase III trial (NCT05631626) evaluating the safety and efficacy of CTx-1301, the 21 adult ADHD patients assessed showed an improvement in ADHD symptoms.

The study’s lead investigator Ann Childress said: “From my observation, the changes in the Adult ADHD Investigator Symptom Rating Scale (AISRS; a scale that measures aspects of ADHD in adults) demonstrated a positive effect in subjects that received CTx-1301 versus subjects that received placebo.

“I was also impressed with the overall improvement (change from baseline) of PERMP scores in subjects who were randomised on CTx-1301 compared to placebo. Although a secondary endpoint, the established CGI scale for the severity of illness demonstrated clinical improvement in the severity of illness. Overall, this in combination with the favourable safety profile bodes well for future Phase III studies.”

The therapy group showed improved performance on the Permanent Product Measure of Performance (PERMP), a scored ten-minute skill-adjusted math test to assess the mental performance of ADHD patients, compared to the placebo group.

The Clinical Global Impression (CGI) Scale for evaluating the severity of ADHD showed a decreased disease severity in the treatment group compared to placebo.

Treatment-emergent adverse events were observed in 9% and 30% of the treatment and placebo groups, respectively.

Patents reported more overall satisfaction with CTx-1301 compared to their prior ADHD medication, as per the company’s press release. Full trial results are expected at upcoming medical meetings.