Recordati announces European approval of silodosin

Recordati announced this week that the European Commission has approved silodosin (urorec/silodix), the firm’s treatment for benign prostatic hyperplasia (BPH), for marketing in the EU.

Related products Urorec and Silodyx have been approved in hard capsule form in doses of 4 mg and 8 mg and product launches are set to take place either by the end of 2010 or early next year.

Two studies into silodosin, the active ingredient of the drugs, found that patients displayed a noticeable decrease in BPH symptoms in both irritative and obstructive terms.

Originally, the compound was developed by Kissei Pharmaceutical and was obtained by Recordati for marketing in 45 European countries.

Giovanni Recordati, chairman and chief executive officer of the firm, said: “The product, under the brands Urorec and Silodyx, will be available in all European markets upon finalisation of the national registration procedures.”

The European Committee for Medicinal Products for Human Use of the European Medicines Agency first offered positive opinions of Urorec and Silodyx in November 2009.