Matrix Receives Action Letter From FDA

Matrix Pharmaceuticals has received an action letter from the US Foodand Drug Administration regarding the New Drug Application for AccuSite (5-flourouracil and adrenaline) Injectable Gel, its genital warts treatment.

The FDA says that the data submitted by Matrix were "inadequate" and that the AccuSite application is "unapprovable as submitted." Issues were raised concerning clinical matters, these being "the importance of the persistance of one side effect as it relates to product equivalence, length of patient follow-up, and a potential risk of serious side effects - though no such side effects were observed in clinical studies," says the company. These matters, it adds, cannot be fully assessed until discussions with the agency have taken place. Chemistry and microbiology issues were also highlighted, although Matrix feels that these will be easily overcome.

Matrix filed its NDA with the agency in September 1995. AccuSite has been approved in the UK (Marketletter June 24, 1996) where it is due to be launched this month. It is under review for marketing approval in France, Italy, Sweden and Germany. In December 1996, Matrix filed for approval in other European countries under the European Union Mutual Recognition procedure.