Lercanidipine suffers another setback
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Forest says further development of the calcium channel blocker lercanidipine would require another extended-release formulation, after the current modified-release version failed to meet dose-response criteria in a Phase II study conducted in response to FDA's August 2002 "approvable" letter. Preliminary results of the eight-week, 60-patient efficacy study indicate lercanidipine was "well tolerated" and had a "clinically relevant reduction in blood pressure." Forest says the positive findings warrant further investigation. A new formulation would mean development "would accordingly be somewhat delayed," the company says. Lercanidipine is already three years behind the original launch projection…