Cingulate Therapeutics said this week that it began a proof-of-concept trial for its controlled-release attention deficit/hyperactivity disorder drug. The 4-week clinical trial is being conducted by its development partner, Bio-Images Drug Delivery.
The trial enrolled healthy volunteers to evaluate the pharmacokinetic behavior of CTX-1301, including the body’s absorption, distribution, metabolism and excretion of the drug. The drug uses multi-core, timed-release technology to last the entire active day and minimize the patient’s “crashing” feeling in the afternoon, according to the company.
The controlled-release OralogiK technology was developed by BDD.
Cingulate said it expects to report findings from the trial in the 3rd quarter of this year.
“The breakthrough multi-core technology employed in CTX-1301 and CTX-1302 combines layers of immediate, delayed and sustained release medication in a single tablet intended to deliver the appropriate dose and at the right time when ADHD patients need it,” chairman & CEO Shane Schaffer said in prepare remarks. “This study intends to demonstrate the ability of our technology to achieve the target product profiles in advance of filing separate IND applications with the U.S. Food & Drug Administration by the end of this year.”
“We are delighted to be working with Cingulate Therapeutics to develop this exciting new product which is now undergoing clinical evaluation using our pharmaco-scintigraphic capabilities,” Carol Thomson, CEO of BDD, added. “The OralogiK technology is uniquely positioned to deliver the tri-phasic release profile required of the CTX-1301 and CTX-1302 products.”