Cingulate Therapeutics, LLC, a clinical stage biopharma company, has entered into service agreements with Camargo Pharmaceutical Services, LLC for regulatory consulting and strategic development services. This includes pre-Investigational New Drug (pre-IND) meeting planning and preparations through New Drug Applications (NDA) submissions, for Cingulate’s two, first-line stimulant medications for the treatment of Attention Deficit – Hyperactivity Disorder (ADHD), CTX-1301 and CTX-1302. Cingulate plans to implement full clinical programs for both drugs in 2018. 

CTX-1301 and CTX-1302 utilize FDA-approved active pharmaceutical ingredients formulated in multi-cored tablets designed to deliver a rapid onset and last the entire active day, while minimizing the afternoon crash and impact on sleep and appetite. Camargo specializes in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act.

Shane J. Schaffer, PharmD, chairman and chief executive officer of Cingulate Therapeutics, said, “Camargo’s deep experience in 505(b)(2) strategy and execution combined with their expertise in navigating regulatory agencies worldwide provides a tremendous advantage to our ambitious pre-IND and overall regulatory strategy. We believe that CTX-1301 and CTX-1302 will become once-daily ADHD medications with the potential to enhance patient care and improve outcomes.”

“Our goal at Camargo is to guide our clients with the most cost- and time-effective strategy to navigate the 505(b)(2) regulatory pathway, while driving commercial success for our partners,” said Ken Phelps, President and CEO of Camargo Pharmaceutical Services. “We are excited to work with Cingulate on regulatory strategy employing innovative technologies with FDA-approved pharmaceuticals to reach unmet needs in the ADHD market.”