CyDex announces first U.S. approval of a Captisol-enabled medicationOVERLAND PARK, KANSAS -- CyDex Inc. has announced the FDA approval of an intravenous form of Vfend (voriconazole), a new antifungal from Pfizer Inc. This formulation combines the active ingredient voriconazole with Captisol, a proprietary CyDex molecule designed to improve the solubility, stability and bioavailability of drug compounds.
"Receiving the first FDA approval for a drug using Captisol is a major milestone for CyDex, and a demonstration of the value of our technologies," said Peter Higuchi, President and CEO of CyDex. "Pfizer is a wonderful partner, and we congratulate our colleagues on bringing Vfend to market as an innovative new therapy for patients with life-threatening fungal infections."
Pfizer received clearance from the U.S. Food and Drug Administration for oral and intravenous use of Vfend in the primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium spp.
The company licensed Captisol from CyDex in 1993, for use in formulations of antifungals and other potential new drugs. Vfend was also recently approved in Europe, and a second Captisol-Enabled compound developed by Pfizer also is progressing through registration.
Captisol is a doughnut-shaped molecule that complexes water insoluble active drugs in its central cavity. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient's bloodstream, where Captisol and the drug disassociate, allowing the active ingredient to produce its desired pharmacological effect.
Source: CyDex, Inc. www.cydexinc.com
Posted: June 2002