Cingulate receives formal pre-NDA meeting minutes from FDA for CTx-1301

Cingulate (CING) announced that it has received formal pre-New Drug Application, NDA, meeting minutes from the U.S. Food and Drug Administration for it’s lead asset CTx-1301 for the treatment of Attention Deficit/Hyperactivity Disorder. Details of the FDA’s minutes include the following, all of which will be a matter of review during the approval process: The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths of 12.5-mg, 18.75-mg, 25-mg, 31.25-mg, 37.5-mg, and 43.75-mg. Cingulate expects shelf-life for all dosage strengths to be 24 months at launch, the results from the aforementioned batches may allow the shelf-life to be extended. Available data for nonclinical safety appears adequate to support a filing. With a scientific bridge established upon review, CTx-1301 may rely on the efficacy and safety data of the listed drug, Focalin XR. Cingulate’s proposed approach to the integrated safety summary and integrated summary of efficacy appears reasonable.