Matrix Pharmaceuticals has launched its chemotherapeutic agent AccusiteInjectable Gel (5-flourouracil and adrenaline) for the treatment of genital warts, in the UK, its first market.
Accusite, Matrix' first product, demonstrated a 75% complete-response rate in clinical trials in patients with an average disease history of two years. The majority remained wart-free three months later, and may be of particular use in patients unresponsive to other therapies or who have a large number of warts, it says. Side effects included local skin reactions and some systemic effects.
Earlier this year, Matrix received an action letter from the US Food and Drug Administration (Marketletter January 13) which said that the data provided by the company to support its application were "inadequate." Accusite was approved, however, by the UK authorities in the summer of last year (Marketletter June 24, 1996). The National Health Service price for Accusite is L72.18 ($120.34) per kit, said a spokesman for the company, and regulatory approvals have been filed in France, Germany, Italy and Sweden, with other European Union approvals to occur under the mutual recognition procedure.
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