Cingulate Gets FDA Complete Response Letter on ADHD Drug

FDA has issued Cingulate a complete response letter (CRL) on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The agency’s concerns were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company, noting that the letter did not identify any current issues related to the drug's clinical safety or efficacy.

CTx-1301 is a once-daily formulation of dexmethylphenidate hydrochloride that uses Cingulate's proprietary Precision Timed Release technology to deliver three scheduled releases of medication throughout the day. The company is pursuing approval through FDA's 505(b)(2) regulatory pathway.

According to Cingulate, work to address the manufacturing-related questions is already underway with its production partner. It expects to submit the requested information promptly and move toward an NDA resubmission.