After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate has suffered a setback in its bid to commercialize its first product.
But the company is taking solace in the fact that it was only manufacturing issues—and not safety or efficacy—that prompted the agency's rejection.
Cingulate has received an FDA complete response letter after submitting its application for CTx-1301, a timed-release version of dexmethylphenidate hydrochloride, to the agency last July as a treatment for attention-deficit/hyperactivity disorder (ADHD). The drug's active ingredient has been available for more than 20 years and was first commercialized as Novartis' Focalin.
In the rejection letter to Cingulate, the FDA flagged "specific Chemistry, Manufacturing and Controls (CMC) information requests," the company said in a June 2 press release, and not any issues related to the candidate's safety or efficacy.
After receiving the CRL, Cingulate's "immediate priority is to complete the CMC work already underway with our manufacturing partner; we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission," CEO Shane J. Schaffer said in a statement.
CTx-1301 is a once-daily, multi-core tablet utilizing Cingulate's proprietary tech designed to deliver three timed releases of dexmethylphenidate hydrochloride during the day. The company touts "rapid" onset with the approach and "all-day efficacy" without the need for a booster.
Besides CTX-1301, the company has another ADHD candidate in the works in CTx-1302 (dextroamphetamine), and it's also developing CTx-2103 (buspirone) for anxiety.
Manufacturing has proven a tricky subject to master for drugmakers of all stripes lately, resulting in FDA rejections for AbbVie, Hyloris and Incyte, to name a few.
As for Cingulate, the biotech touts more than $30 million in cash reserves, money the company believes will enable it to respond to the FDA's questions and continue to prepare for a potential launch.