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news.Prism Pharmaceuticals' NexterOne (amiodarone HCL) Premixed injection, which recently received supplemental new drug application (sNDA) approval from the US Food and Drug Administration, has used CyDex Pharmaceuticals patent-protected Captisol technology platform.
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CyDex claimed that 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’s Captisol technology improves the water solubility and stability of active pharmaceutical ingredients, which 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.
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, while the second patent protects a 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 president and CEO Theron Odlaug said that CyDex has provided Prism Pharmaceuticals with technical support since they first licensed the worldwide rights to a Captisol-enabled amiodarone HCL formulation from them in 2006.
"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 new products for intravenous therapy in the hospital setting, but also the productivity of this longstanding licensing relationship," Odlaug said.
"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 products for acute care hospital applications."