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FDA Approves Ready-to-Use Nexterone Premixed Injection

Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection

KING OF PRUSSIA, Pa., Nov. 18, 2010 /PRNewswire/ -- Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved the supplemental new drug application for Nexterone (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV. Nexterone Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Nexterone Premixed Injection is approved in two ready-to-use dosage forms with strengths of 1.5 mg/mL (150 mg/100 mL) for rapid loading infusion and 1.8 mg/mL (360 mg/200 mL) for subsequent infusion.

"Until now, amiodarone IV required admixture at time of use. Nexterone Premixed Injection overcomes the need to admix amiodarone IV, thereby eliminating the potential for medication admixture error," said Dr. Warren D. Cooper, President and CEO of Prism. "The ready-to-use packaging is designed for the storage of Nexterone Premixed Injection at the point of use in automated dispensing cabinets and crash carts and offers a two-year shelf life."

Manufacturer-prepared, premixed ready-to-use products represent a preferred approach, when available, to advance initiatives and professional standards for improving IV drug safety. Organizations that promote, support, and monitor implementation of practices intended to assure quality services in the hospital environment include the Joint Commission, the United States Pharmacopeia (USP) and the American Society of Health System Pharmacists (ASHP).

Nexterone Premixed Injection is manufactured for Prism Pharmaceuticals, Inc. by Baxter Healthcare Corporation using Baxter's proprietary GALAXY container technology.

About Ventricular Fibrillation and Ventricular Tachycardia

Ventricular fibrillation is a condition in which the heart's electrical activity becomes disordered. When this happens, the heart's lower (pumping) chambers, called ventricles, contract in a rapid, unsynchronized way. (the ventricles "flutter" rather than beat). The heart pumps little or no blood. Ventricular fibrillation is very serious. Collapse and sudden cardiac death will follow in minutes unless medical help is provided immediately.

Ventricular tachycardia is a fast or rapid heart rate that starts in the heart's lower chambers. Ventricular tachycardia may result from serious heart disease and usually requires prompt treatment.

Important Safety Information about Nexterone

Nexterone is contraindicated in patients with: known hypersensitivity to any of the components of Nexterone, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. If hypotension occurs, treat initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. If bradycardia and AV block occur, treat by slowing the infusion rate or discontinuing Nexterone. The most common adverse reactions (1–2 percent) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, ventricular tachycardia (VT), and cardiogenic shock. Other important adverse reactions are torsade de pointes (TdP), congestive heart failure, pulmonary disorders, and liver function test abnormalities.

For more information about Nexterone, including full prescribing information, visit www.prismpharma.com.

About Prism Pharmaceuticals, Inc.

Prism Pharmaceuticals, Inc., based in King of Prussia, Pennsylvania, is a specialty pharmaceutical company committed to developing and commercializing acute care cardiovascular products.

Prism was started in 2004 with a founding investment from Essex Woodlands Health Ventures (www.ewhv.com). In 2006, Prism secured a $68 million layered financing of equity from Essex combined with equity and a revenue interest agreement from Paul Capital Healthcare (www.paulcapitalhealthcare.com). This level of sustaining investment has enabled Prism to pursue an aggressive licensing and rapid development model resulting in the successful approval of Nexterone.

The worldwide rights to Nexterone were licensed in early 2006 from CyDex Pharmaceuticals, Inc. (www.cydexpharma.com). Nexterone is based on the CyDex patent-protected CAPTISOL technology platform.

For further information, visit www.prismpharma.com.

Nexterone is a registered trademark of Prism Pharmaceuticals, Inc.

CAPTISOL is a registered trademark of CyDex

Galaxy is a registered trademark of Baxter International Inc.


SOURCE Prism Pharmaceuticals, Inc.

Posted: November 2010

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