FDA accepts anti-arrhythmic agent NDA from Prism, Cydex

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CyDex Pharmaceuticals has reported that Prism Pharmaceuticals’ Nexterone, which is based on the patent-protected CyDex Captisol technology platform, has received new drug application (NDA) approval from the FDA.

The Lenexa, Kansas-based CyDex said Nexterone is its first proprietary product to achieve an NDA approval. According to the company, Captisol technology improves the water solubility and stability of active pharmaceutical ingredients. The tool allowed the King of Prussia, Pa.-based Prism to develop a formulation of the anti-arrhythmic agent Amiodarone IV (originally marketed as Cordarone Intravenous) without the cosolvents polysorbate 80 and benzyl alcohol that are used in the innovator product.