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news.IntelGenx, a drug delivery company, and Cary Pharmaceuticals, a specialty pharmaceutical company, have submitted a new drug application to the FDA for their antidepressant CPI-300, a new strength of antidepressant that will provide a more convenient dosing option to patients with major depressive disorder.
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IntelGenx and Cary Pharma have previously entered into a collaborative agreement to jointly develop and commercialize CPI-300 using IntelGenx’s oral delivery technology.
Under the terms of the collaborative agreement, IntelGenx raised $2 million in March 2008 to fund completion of the product development and Cary Pharma acted as the applicant for the submission of the new drug application (NDA). Upon commercialization of the product, IntelGenx and Cary Pharma would share profits.
Horst Zerbe, president and CEO of IntelGenx, said: “The filing of the 505(b)(2) NDA for CPI-300 is an important milestone for IntelGenx as we move one step closer to bringing forth a new treatment option for patients with major depressive disorder.”