Pharma Focus Asia

Cingulate Therapeutics Partners with Camargo Pharmaceutical Services for Development Programs

Wednesday, August 09, 2017

Cingulate Therapeutics, LLC, a clinical stage biopharmaceutical company focused on the development of new and innovative products for the treatment of Attention Deficit – Hyperactivity Disorder (ADHD), today announced that it has entered into service agreements with Camargo Pharmaceutical Services, LLC ("Camargo"). Camargo will provide end-to-end regulatory consulting and strategic development services including pre-Investigational New Drug (pre-IND) meeting planning and preparations through New Drug Applications (NDA) submissions, for Cingulate's two (2) proprietary, first-line stimulant medications for the treatment of Attention Deficit – Hyperactivity Disorder (ADHD), CTX-1301 and CTX-1302. After receiving data from initial proof of concept trials in humans, Cingulate plans to implement full clinical plans for both CTX-1301 and CTX-1302 in 2018.

CTX-1301 and CTX-1302 utilize FDA-approved active pharmaceutical ingredients formulated in innovative, multi-cored tablets that have target product profiles designed to deliver a rapid onset and last the entire active day while minimizing the afternoon crash and impact on sleep and appetite. Camargo is a highly experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1,100 FDA meetings and more than 200 FDA, NDA, and ANDA approvals.

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."

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