Cingulate has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for CTx-1301, its investigational treatment for attention-deficit/hyperactivity disorder (ADHD), after submitting its application to the agency in July of last year.
The Kansas City-based drug developer said the FDA’s response was tied to manufacturing-related matters rather than concerns about the drug itself. According to the company, the agency requested specific Chemistry, Manufacturing and Controls (CMC) information and did not raise issues regarding the safety or effectiveness of the treatment.
CTx-1301 is a once-daily, timed-release formulation of dexmethylphenidate hydrochloride, an active ingredient that has been available in approved ADHD medications for more than 20 years. The ingredient was first commercialized by Novartis as Focalin. Dexmethylphenidate belongs to a class of stimulant medicines that work by increasing the activity of dopamine and norepinephrine, brain chemicals involved in attention and behavior.
The company said the FDA’s complete response letter focused on manufacturing information requests. Cingulate emphasized that the agency did not identify deficiencies related to the candidate’s safety profile or its effectiveness as a treatment for ADHD.
“Our 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,” Chief Executive Officer Shane Schaffer said.
Following receipt of the letter, Cingulate said it plans to promptly provide the requested information and continue working toward a resubmission of its application.
CTx-1301 is designed using Cingulate’s proprietary multi-core tablet technology. The formulation delivers three timed releases of dexmethylphenidate during the day through a single daily dose. According to the company, the approach is intended to provide rapid onset and all-day efficacy without the need for a booster dose later in the day.
The company has also stated that the product is being developed to address midday wear-off associated with existing ADHD treatments and potentially improve adherence. A comparable product, Novartis’ Focalin XR, contains the same active ingredient but utilizes a two-stage release system rather than the three-stage release employed by CTx-1301.
Beyond CTx-1301, Cingulate’s development pipeline includes CTx-1302, a dextroamphetamine-based ADHD candidate, and CTx-2103, a buspirone-based candidate being studied for anxiety.
Cingulate said it has nearly $30 million in cash reserves. The company believes those funds will allow it to address the FDA’s manufacturing requests, support the resubmission process, and continue preparing for a potential product launch while funding operations into 2027.
Manufacturing-related issues have recently resulted in FDA rejections for other drugmakers, including AbbVie, Hyloris and Incyte, according to information cited by Cingulate.
If approved, CTx-1301 would enter an ADHD treatment market that includes products such as Takeda Pharmaceutical’s Vyvanse and Johnson & Johnson’s Concerta. The drug is intended to treat ADHD, a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsive behavior that can affect children and continue into adulthood.
Cingulate said it will continue its efforts to complete the requested CMC work and provide the information sought by the FDA as it prepares a resubmission of the application.
Cingulate has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its investigational attention-deficit/hyperactivity disorder (ADHD) treatment, CTx-1301. According to the announcement, the FDA’s concerns are primarily related to manufacturing and production processes rather than the safety or effectiveness of the therapy itself.
The development represents an important regulatory milestone for Cingulate as the company works to address the agency’s questions and advance the approval process for CTx-1301.
Understanding the FDA’s Complete Response Letter
A Complete Response Letter is issued when the FDA determines that it cannot approve a drug application in its current form. In the case of Cingulate, the FDA requested additional information related to manufacturing requirements and quality controls associated with CTx-1301.
While the letter delays approval, Cingulate indicated that the FDA did not identify concerns regarding the clinical performance of the ADHD medication.
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