The FDA has issued a complete response letter for Cingulate’s new drug application seeking approval of CTx-1301 for the treatment of attention-deficit/hyperactivity disorder.
The agency’s response identified specific Chemistry, Manufacturing and Controls information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301 (dexmethylphenidate HCl), according to a June 2 news release from the drugmaker.
CTx-1301 takes a familiar molecule — dexmethylphenidate, the active form of a decades-old ADHD stimulant — and rebuilds how it is delivered: one tablet that releases medication three separate times throughout the day, rather than all at once or in a slow, continuous drip.
Cingulate said it expects to promptly submit the requested information to address the issues raised by the FDA.
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