Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
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.
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
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 for the accreditation of
hospitals, and the Institute for Safe Medication Practices. Providing
injectable products, especially those for critical care use, in premixed,
ready to use forms is a high priority solution to minimize medication errors.
Dr. Cooper continued, “While this regulatory approval is for NEXTERONE
supplied in vials and a prefilled syringe, the changes in the compatibility
and stability profile of NEXTERONE, brought about by the removal of
polysorbate 80 and benzyl alcohol, present the opportunity to formulate
intravenous amiodarone for the first time in premixed, ready to use
Prism is currently implementing a full scale manufacturing development
program with the Medication Delivery business of Baxter Healthcare
Corporation, a world leader in premix technologies. Prism intends to submit a
supplemental NDA for the premixed configurations which will form the focus of
the commercial launch of NEXTERONE as a complete product line. Health-System
Pharmacists hold the primary management responsibility for improvements in
medication safety in hospitals and this will be a key target customer group
“We intend to commercialize NEXTERONE ourselves in the US with partners
that are well positioned in the hospital marketplace and will seek to license
the ex-US worldwide rights,” said Dr. Cooper. “As we round out the NEXTERONE
product line with the premixed bag configurations, we are concurrently
defining the best approach to launch the brand, drive rapid conversion and
optimize the value of NEXTERONE to pharmacists, clinicians, patients and the
Company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when
it becomes available and has the potential to eventually render conventional
Amiodarone IV obsolete.”
The FDA approval of NEXTERONE triggers a second
from Paul Capital. This long range financing agreement, established in
to bring NEXTERONE through the period of NDA review and commercial launch.
Dr. Cooper will present the corporate strategy for PRISM Pharmaceuticals,
the commercial plans for NEXTERONE and the product pipeline at the 27th Annual
JP Morgan Healthcare Conference on
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 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 (ventricles). Ventricular tachycardia may result from
serious heart disease and usually requires prompt treatment.
Important Safety Information About NEXTERONE
The most important treatment-emergent adverse effects associated with
intravenous amiodarone therapy in clinical studies were hypotension,
asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic
shock, congestive heart failure, bradycardia, liver function test
abnormalities, ventricular tachycardia, and atrioventricular block. Overall,
treatment was discontinued for about 9 percent of the patients because of
adverse effects. The most common adverse effects leading to discontinuation
of intravenous amiodarone therapy were hypotension (1.6 percent),
asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1
percent), and cardiogenic shock (1 percent).
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 AV
block unless a functioning pacemaker is available.
NEXTERONE is for hospital use only. NEXTERONE should be administered only
by physicians who are experienced in the treatment of life-threatening
arrhythmias, who are thoroughly familiar with the risks and benefits of
intravenous amiodarone therapy, and who have access to facilities adequate for
monitoring the effectiveness and side effects of treatment.
For more information about NEXTERONE, including full prescribing
information, visit http://www.prismpharma.com.
About Prism Pharmaceuticals
Prism Pharmaceuticals, based in
specialty pharmaceutical company committed to developing and commercializing
acute care cardiovascular products. The product portfolio strategy is focused
on recognizing unfulfilled opportunities in existing compounds that address
current unmet medical needs with a specific focus on medication safety in the
Prism was started in 2004 with a founding investment from Essex Woodlands
Health Ventures (http://www.ewhv.com). In 2006 Prism secured a
financing of equity from Essex combined with equity and a revenue interest
agreement from Paul Capital (http://www.paulcap.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 (http://www.cydexpharma.com). NEXTERONE is based on the CyDex
patent-protected CAPTISOL(R) technology platform. Prism and CyDex are also
developing a novel injectable form of the blockbuster antiplatelet agent
PLAVIX(R) (clopidogrel) for use in acute care situations overcoming the
limitations of the current product which is only available as an oral therapy.
For further information, visit http://www.prismpharma.com.
NEXTERONE(R) is a registered trademark of Prism Pharmaceuticals, Inc.
Cordarone(R) and PLAVIX(R) are registered trademarks of sanofi-aventis.
SOURCE Prism Pharmaceuticals