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Press Release - IntelGenx Corp. (IGXT.OB-OTC: BB) |
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“Our focus is on oral drug delivery. Our platform technologies include systems for controlled release and immediate release dosage forms. Our controlled-release technology is based on layered tablets that consist of a non-erodible layer containing the active drug and one or more erodible cover layers. Upon contact of the tablet with the gastro-intestinal fluid, the cover layers erode at a pre-determined rate. This “controlled erosion” controls the release of an active drug from the...” - Horst G. Zerbe, Ph.D. (IGXT) (Interview published July 25, 2008) |
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IntelGenx Corp. Set to File NDA for
Antidepressant SAINT LAURENT, QUEBEC and GREAT FALLS, VIRGINIA--(MARKET WIRE)--Oct 9, 2008 -- IntelGenx Corp. (Toronto:IGX.TO - News)(OTC BB:IGXT.OB - News) ("IntelGenx") and Cary Pharmaceuticals Inc. ("Cary Pharma") today announced positive results from a clinical trial on its antidepressant CPI 300. The results from the bioequivalence study undertaken in September 2008 confirm that CPI 300 is bioequivalent to the reference product. IntelGenx and Cary Pharma will be filing a New Drug Application ("NDA") (505(b)(2) based on the successful results of this study. Approval of the product is expected during the second half of 2009.
CPI-300 was formulated using IntelGenx's proprietary controlled release technology. It contains a new strength of antidepressant developed to complete the dosing options for physicians who currently prescribe the drug. CPI-300 provides a more convenient dosing option for those patients currently taking the higher strength. It will be indicated for the treatment of major depressive disorder (MDD).
Major depressive disorder is also known as major depression, clinical depression, or unipolar depression. Major Depressive Disorder is the leading cause of disability in the U.S. for ages 15-44. It affects approximately 14.8 million American adults, or about 6.7 percent of the U.S. population age 18 and older in a given year.
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. The Company uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastro-intestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. The Company's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders. More information is available about the company at www.intelgenx.com.
Cary Pharmaceuticals Inc. is a specialty pharmaceutical company located in Northern Virginia. The company's product pipeline includes CPI-300 for the treatment of depression, and QuitPak® for smoking cessation.
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO (514) 331-7440 x201 Email: horst@IntelGenx.com Website: http://www.intelgenx.com Cary Pharmaceuticals Inc. Douglas D. Cary President and CEO (703) 759-7460 Email: doug.cary@carypharma.com Website: http://www.carypharma.com Source: IntelGenx Corp.
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