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news.IntelGenx, a drug delivery company, and Cary Pharmaceuticals, a specialty pharmaceutical company, have announced positive results from a clinical trial of its antidepressant CPI 300. The companies are expected to file a new drug application based on the successful results of this study.
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The results from the bioequivalence study undertaken in September 2008 confirm that CPI 300 is bioequivalent to the reference product. Approval of the product is expected during the second half of 2009.
Horst Zerbe, president and CEO of IntelGenx, said: “We are now able to concentrate our efforts on completing the compilation of documentation for the 505(b)(2) NDA filing with the FDA. I am very proud of our team of experts who not only successfully developed this product within the allotted time frame, but also within budget.”
Douglas Cary, president and CEO of Cary Pharmaceuticals, said: “Our research shows that more than one million prescriptions were dispensed for the higher dosage of this antidepressant during 2007 and we will be the sole provider of this medication in a single tablet. I am very excited by these results.”