KANSAS CITY, Kan. and CINCINNATI, Aug. 8, 2017 /PRNewswire/ -- 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."
About Cingulate Therapeutics
Cingulate Therapeutics, LLC is a privately held clinical stage biopharmaceutical company focused on the development of new and innovative products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Cingulate is developing two (2) proprietary, first-line medications, CTX-1301 (Dexmethylphenidate) and CTX-1302 (Dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents and adults. CTX-1301 and CTX-1302 utilize an innovative, flexible core tableting technology with a Target Product Profile designed to deliver a rapid onset and last the entire active day while minimizing the afternoon crash and impact on sleep and appetite. The Company has completed a Proof of Concept Phase I clinical trial and plans to implement the full clinical plan for both CTX-1301 and CTX-1302 in early 2018. Cingulate anticipates filing INDs for both products in the first quarter of 2018 and will pursue approval via the accelerated 505(b)(2) regulatory pathway. The company has offices in Kansas City, KS and Morristown, NJ. For more information visit www.cingulatetherapeutics.com.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six Agency meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit https://CamargoPharma.com
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SOURCE Cingulate Therapeutics, LLC