Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular T... ( KING OF PRUSSIA Pa. Jan. 5 /- Pri...)

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Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Date:1/5/2009

KING OF PRUSSIA, Pa., Jan. 5 /PRNewswire/ -- Prism Pharmaceuticals announced today that the U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R) Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

"Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move NEXTERONE from licensing to FDA clearance in less than three years and ahead of the PDUFA target date," said Dr. Warren D. Cooper, President and CEO of Prism. "We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias."

NEXTERONE represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, NEXTERONE does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, NEXTERONE does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol.

Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as The Joint Commission, which is responsible
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