CyDex Inc announced the second U.S. approval of a Captisol-Enabled product - Geodon for Injection (ziprasidone mesylate), the first atypical antipsychotic intramuscular therapy for rapid control of acute agitation in schizophrenia from Pfizer Inc. Captisol is an advanced formulation system that improves the solubility of drug compounds.
"The U.S. market launch of the second innovative Pfizer drug using Captisol is a very exciting milestone and provides further commercial and regulatory validation of our technology," said Peter Higuchi, President and CEO of CyDex. "The Captisol technology is proving its versatility by enabling our partners to meet patient needs in different therapeutic areas with different methods of administration."
Pfizer received clearance from the Food and Drug Administration for use of Geodon for Injection to rapidly control agitated behavior in patients with schizophrenia. Geodon for Injection , an intramuscular formulation for acute therapy, complements Geodon (ziprasidone HCl) capsules that have been available in the United States since the first quarter of 2001. Pfizer first launched both the oral and intramuscular forms in 2000 in Sweden (under the trade names Zeldox and Zeldox IM). Zeldox IM is currently approved in seventeen other countries including Germany, Spain and Brazil .
On May 28, 2002, Pfizer received U.S. approval for Vfend (voriconazole), a new medication for invasive fungal infections - with an intravenous formulation based on Captisol technology. Pfizer licensed Captisol from CyDex in 1993 for formulation of potential new drugs.
Captisol enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. Captisol is a donut-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 dissociate, allowing the active ingredient to produce its desired pharmacological effect.