Cingulate receives confirmation from FDA on NDA for CTx-1301

Cingulate announced that it has received confirmation from and is aligned with the U.S. Food and Drug Administration, FDA, on the requirements necessary for filing a New Drug Application, NDA, for its lead Phase 3 candidate CTx-1301, for the treatment of Attention Deficit Hyperactivity Disorder, ADHD, in patients six years of age or older. Details from the FDA communication to Cingulate include the following: Per the 505(b)(2) pathway, submission of CTx-1301’s NDA does not require continuation of the fixed dose study and the onset and duration study; Data collected to date from these two Phase 3 studies will be included in the filing; and Contemporaneously with the preparation of the NDA filing, Cingulate will conduct a Phase 1 fed/fast study, the study is expected to last approximately two to three weeks, with the results being included in the NDA filing.