RYE, New York, Nov. 4, 2013 — Curemark LLC announced that it has begun the rolling submission of a New Drug Application (NDA) for CM-AT, the company’s autism treatment, with the U.S. Food and Drug Administration.
CM-AT had previously been granted Fast Track status by the FDA, a designation given to drug candidates that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The rolling submission process allows companies with a Fast Track designation to submit the NDA in sections to the FDA as they are completed.
“Initiating our “rolling NDA’ submission is a major step in the registration process for CM-AT,” said Dr. Joan Fallon, Curemark founder and CEO. “We have an extraordinary opportunity to help many children with autism improve the quality of their lives and we will continue to work closely with the FDA to make that happen.”
Curemark previously announced the successful completion of its Phase III multicenter clinical trial of CM-AT for autism. CM-AT met both primary and secondary endpoints in its double-blind, randomized, placebo-controlled study of children with autism at 3 to 8 years of age.
Curemark is a drug research and development company focused on the treatment of neurological and other diseases, especially those with dysautonomic components, by addressing certain key gastrointestinal/pancreatic secretory deficiencies. The company previously announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. To learn more about our innovative science, visit www.curemark.com
This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of the Curemark products CM-AT, CM-4612 and CM-182 their potential advantages, their potential for use in treating diseases or disorders, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning the Curemark products CM-AT, CM-4612 and CM-182. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the Curemark products CM-AT, CM-4612 and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182 regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.