NEXTERONE Premixed Injection uses CyDex Captisol technology platform

CyDex Pharmaceuticals, Inc. today announced that Prism Pharmaceuticals' NEXTERONE^® (amiodarone HCL) Premixed Injection, which recently received supplemental new drug application (sNDA) approval from the U.S. Food and Drug Administration, makes use of the patent-protected CyDex Captisol^® technology platform. The new product is a premixed intravenous (IV) bag formulation of Prism Pharmaceuticals' NEXTERONE Injection, which was the first CyDex licensed proprietary product to achieve NDA approval.

“CyDex has provided Prism Pharmaceuticals with technical support since they first licensed the worldwide rights to a Captisol-enabled® amiodarone HCL formulation from us in 2006”

CyDex's Captisol technology improves the water solubility and stability of active pharmaceutical ingredients. Using Captisol enabled Prism Pharmaceuticals to formulate NEXTERONE Premixed Injection without the cosolvents polysorbate 80 and benzyl alcohol used in the innovator product - the antiarrhythmic agent amiodarone IV originally marketed as Cordarone^® Intravenous. Cosolvent-free NEXTERONE Premixed Injection does not require admixture at the time of use, enabling the product to be premixed and remain stable in storage for as long as two years.

Captisol is protected by two recently granted patents; one is a new Captisol morphology that flows better, dissolves faster and packs more densely than previous material. The second patent protects an innovative process for manufacturing high-purity Captisol that removes impurities resulting in a new composition of matter, which further increases the stability of sensitive active pharmaceutical ingredients.

"CyDex has provided Prism Pharmaceuticals with technical support since they first licensed the worldwide rights to a Captisol-enabled^® amiodarone HCL formulation from us in 2006," said Theron E. Odlaug, CyDex's president and chief executive officer. "Prism's success in advancing this new, premixed IV bag formulation of NEXTERONE demonstrates not only the role Captisol can play in the development of novel products for intravenous therapy in the hospital setting, but also the productivity of this longstanding licensing relationship. It also underscores the value of our recent patents in providing our licensing partners with broader intellectual property protection and enhanced product life-cycle management capabilities. At the same time, as the fifth product commercially marketed by a CyDex partner, NEXTERONE Premixed Injection has the potential to further expand our licensing royalty revenue base as we continue to expand our portfolio of innovative products for acute care hospital applications."