CyDex Pharmaceuticals, Inc announced that Prism Pharmaceuticals' Nexterone, which recently received new drug application (NDA) approval from the US Food and Drug Administration (FDA), is based on the patent protected CyDex Captisol technology platform. Nexterone is the first CyDex proprietary product to achieve the milestone of NDA approval. Captisol technology improves the water solubility and stability of active pharmaceutical ingredients. It thereby allowed Prism Pharmaceuticals, Inc to develop a novel formulation of the antiarrhythmic agent Amiodarone IV (originally marketed as Cordarone Intravenous) without the cosolvents polysorbate 80 and benzyl alcohol that are used in the innovator product. Cosolvent-free Nexterone addresses the patient care and medication management limitations of conventional intravenous amiodarone in treatment of life-threatening cardiac arrhythmias.

"Prism licensed the worldwide rights to an amiodarone formulation developed with Captisol technology from CyDex in early 2006, and we have worked closely with Prism in providing technical support since then," said Theron E Odlaug, CyDex president and chief executive officer. "Along with our technical support, their success in advancing the product to NDA approval in less than three years further demonstrates the value of Captisol technology in developing novel injectable products that enhance patient treatment in the hospital setting. Nexterone's approval also marks two corporate milestones for CyDex. It is the first of our products formulated in-house to receive FDA approval and, as the fifth product marketed by a CyDex licensing partner, it has the potential to significantly expand our licensing royalty revenue base."

CyDex and Prism also have been jointly developing a novel Captisol-enabled injectable form of the antiplatelet agent clopidogrel, originally marketed as Plavix, for use in cardiovascular surgery. Clopidogrel is currently available only as an oral therapy. Adding an injectable route for clopidogrel will provide interventional cardiologists more direct control over patient care, and reduce the pre-procedural time required over the oral drug.

"Expanding our Captisol technology licensing business with valued partners such as Prism complements CyDex's core strategy, which is to develop and market our own line of specialty pharmaceutical injectable products that target unmet needs in intravenous therapy," said Odlaug. "We are proud to have Prism as one of our expanding group of CyDex licensing partners, and we look forward to successfully completing clinical development of clopidogrel."

CyDex Pharmaceuticals is a specialty pharmaceutical company developing products and licensing its Captisol technology.