Kansas, USA-based CyDex has signed a license and supply agreement granting exclusive worldwide rights to its Captisol enabling technology to fellow USA-based Critical Therapeutics for the development of an injectable formulation of zileuton. Critical Therapeutics, and its co-promotion partner Dey, currently market the asthma drug as Zyflo in the USA.
On May 30, the US Food and Drug Administration approved twice-daily Zyflo CR extended-release tablets. Critical Therapeutics and Dey expect to begin marketing the drug in the USA in the fall. The agent is indicated for the prevention and treatment of asthma in adults and children 12 years of age and older.
The injectable formulation of zileuton is being developed for use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma. CyDex' patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs.
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