ARTICLE | Clinical News

CPI-300 regulatory update

August 30, 2010 7:00 AM UTC

After meeting with the FDA, IntelGenx said it now plans to respond to a February complete response letter for CPI-300 to treat major depressive disorder (MDD) in 1Q11 rather than this half. The company said it plans to address FDA's two main questions by submitting stability data to support a new manufacturing site and conducting clinical work to address the effect of food on CPI-300. CPI-300 is an oral antidepressant containing a high-strength formulation of bupropion developed using IntelGenx's controlled-release drug delivery technology. ...