Pharmaprojects R&D Pipeline News Feed
First approval for Prism Pharmaceuticals
16 Jan 2009
Prism Pharmaceuticals has received US approval for Nexterone, its intravenous formulation of the antiarrhythmic amiodarone, for the treatment of ventricular fibrillation and haemodynamically unstable ventricular tachycardia.
The solvent-free formulation is supplied as prefilled syringes, and has several administration advantages over conventional amiodarone. An sNDA for premixed formulations is also planned.
The approval of Nexterone represents the first approval of a product by Prism Pharmaceuticals, with Nexterone moving from licensing to FDA clearance in less than 3 years. Nexterone is now the most clinically advanced reformulation of amiodarone, with Cydex's Captisol amiodarone formulation still in Phase III trials. Prism will commercialize Nexterone in the US, and intends to out-license ex-US rights.
