Cingulate publishes PK data for ADHD drug CTx-1301 in CNS Drugs

Cingulate Inc. (NASDAQ: CING) announced the publication of pharmacokinetic data for its ADHD drug candidate CTx-1301 in the peer-reviewed journal CNS Drugs, according to a press release from the company.

The study, titled "Comparative Bioavailability of Trimodal CTx-1301 Versus Bimodal Dexmethylphenidate," evaluated CTx-1301 (dexmethylphenidate HCl) against a commercially available bimodal dexmethylphenidate formulation in a randomized, crossover study of adult subjects with ADHD.

The publication reports that CTx-1301 achieved plasma dexmethylphenidate concentrations comparable to the reference product early in the dosing interval while maintaining statistically significant higher plasma concentrations later in the day. The study also found that CTx-1301 produced fewer treatment-emergent adverse events than the reference bimodal formulation, despite delivering a higher overall dexmethylphenidate dose.

CTx-1301 uses Cingulate's Precision Timed Release platform to deliver three timed releases of active medication across the day. The drug is being evaluated under the FDA's 505(b)(2) regulatory pathway.

The pharmacokinetic publication follows a previously published Phase 3 efficacy and safety study that appeared in the Journal of Child and Adolescent Psychopharmacology.

"This study demonstrates that CTx-1301 was designed as a true once-daily medication, delivering three distinct releases of dexmethylphenidate that create a pharmacokinetic profile different from currently available stimulant formulations," said Ann Childress, MD, lead investigator for Cingulate's Phase 3 trial.

The manuscript is available through open access at the journal's website.

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