FDA posts Pulzium briefing documents

FDA posted additional briefing documents for a Dec. 11-12 meeting to discuss therapies for acute conversion of heart arrhythmias. According to the documents for Pulzium tedisamil from Solvay (Euronext:SOLB), members of the Cardiovascular & Renal Drugs Advisory Committee will be asked to discuss the complex dosing regimen proposed for the Class III anti-arrhythmic compound that blocks multiple K channels, as well as the proposed risk management plan and potential safety issues including torsades de pointes, bradycardia and thromboembolic events. Documents for vernakalant, a mixed ion channel antagonist from Astellas (Tokyo:4503) and Cardiome (TSX:COM; CRME), were posted Friday (See BioCentury Extra, Friday, Dec. 07, 2007). ...