Positive top-line results announced in study of ADHD therapeutic
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A Kansas-based biopharmaceutical company has announced positive top-line results from a study assessing the effect of food on absorption of its investigational extended-release tablet therapeutic CTx-1301 to treat ADHD.
According to a press release from Cingulate, CTx-1301 is a novel, trimodal formulation of dexmethylphenidate that increases norepinephrine and dopamine activity in the brain to positively alter attention and behavior.
The trial (CTx-1301-003) involved 23 healthy adult participants aged 18 to 50 years, randomized into one of two sequences to receive one 25 mg dose of CTx-1301 with a standard high fat breakfast and one without food. Both doses were administered with 8 ounces of water, and blood samples were taken up to 28 hours after each dose to define absorption and elimination profile of the drug. Ultimately, the study demonstrated CTx-1301 can be taken with or without food, the company said in the release.
“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,” Cingulate CEO and Chairman Shane J. Schaffer, PharmD, said in the release.
Cingulate additionally announced initiation of its initial phase 3 trial for CTx-1301, an adult dose-optimization safety and efficacy study to assess onset and duration, with results expected in the third quarter of 2023. The company also said it plans to initiate a second phase 3 study, a fixed-dose, placebo-controlled trial in pediatric and adolescent patients with ADHD, by the middle of the year.
“The ability to provide patients with a once-daily treatment that has the flexibility to be taken with or without food and delivers fast onset, a favorable tolerability profile, and entire active-day efficacy addresses the biggest unmet needs facing ADHD patients and providers,” Cingulate chief medical officer Matthew Brams, MD, said in the release.