Positive Top-Line Results Reported for Fed/Fast Study of Novel ADHD Treatment

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Positive top-line results were reported for a study of a novel formulation of dexmethylphenidate for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The fed/fast study, CTx-1301-003, is an endeavor by Cingulate Inc. to assess the effect of food on the absorption of CTx-1301, an investigational, trimodal, extended-release, novel, tablet formulation of dexmethylphenidate, which has been approved by the US Food & Drug Administration (FDA) for the treatment of ADHD. The positive top-line results indicated that CTx-1301 can be taken either with or without food, and that adverse events were consistent with findings from prior studies and indicative of a favorable tolerability profile.¹

“The positive results of the CTX-1301 fed/fast study will be very encouraging to providers who treat ADHD. It means that there are minimal food effects, and children, adolescents, and adults can achieve consistent blood levels despite the degree of food intake,” Matthew Brams, MD, chief medical officer at Cingulate, told Psychiatric Times™. “The study confirms our confidence in our delivery system being minimally affected by food intake and is a positive milestone on our way to further development of our lead asset.”

Following its announcement of the first Phase 3 trial—a fixed-dose, placebo-controlled study involving both pediatric and adolescent participants with ADHD—for CTx-1301 in January,² Cingulate plans to initiate the Phase 3 trial in mid-2023, with results expected in the third quarter of the year.¹

“We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, chairman and CEO at Cingulate, in a news release. “The results of this study are instrumental in confirming that we have identified the optimal formulation of CTx-1301, paving the way for our Phase 3 trials.”

References

1. Cingulate announces positive top-line results from fed/fast study of lead asset CTx-1301 for ADHD. News release. Cingulate Inc. February 23, 2023. Accessed March 2, 2023. https://www.cingulate.com/news-releases/news-release-details/cingulate-announces-positive-top-line-results-fedfast-study-lead

2. Cingulate initiates Phase 3 study of lead asset CTx-1301, designed as a true entire active-day treatment for ADHD. News release. Cingulate Inc. January 4, 2023. Accessed March 2, 2023. https://www.cingulate.com/news-releases/news-release-details/cingulate-initiates-phase-3-study-lead-asset-ctx-1301-designed