Cornerstone Therapeutics Inc, a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, has submitted a regulatory filing with the US Food and Drug Administration (FDA) for an extended-release antitussive product (CRTX 067) that, if approved, would compete directly in the large prescription antitussive market. Depending upon the timing of FDA approval, Cornerstone expects that the product could be commercially available in 2011.

Cough is one of the most common symptoms prompting patients to see their primary care physician. According to data derived from Source Pharmaceutical Audit Suite, January-December 2008, Wolters Kluwer Health, in 2008, there were over 30 million prescriptions and nearly $1 billion dollars in sales generated for oral antitussives; however, most oral antitussive products that are currently marketed are in an immediate-release formulation (over 25 million prescriptions annually) requiring dosing every four to six hours, which can be inconvenient and adversely affect patient compliance. Cornerstone believes that its antitussive product may improve patient compliance by providing more convenient twice-daily dosing.

"This is an important regulatory submission for Cornerstone, as it is the first of several applications for which we plan to seek FDA approval over the next few years," said Craig Collard, president and CEO of Cornerstone. "This antitussive product is an important part of our overall corporate strategy to compete in the prescription Cough and Cold Preparations market, which represents over 40 million prescriptions annually."

Cornerstone Therapeutics, headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets.