FDA approves two-drug combination for BPH

May 9, 2004

The FDA has approved changes to the prescribing information for finasteride(Proscar) based on results of the landmark Medical Therapy of ProstaticSymptoms (MTOPS) study. Under the new approval, finasteride administeredin combination with doxazosin (Cardura) is indicated to reduce the riskof symptoms of BPH from progressing over time (a confirmed rise of fouror more points in AUA symptom score). MTOPS showed that the two-drug combinationsignificantly reduced the risk of BPH symptoms progressing versus placeboand versus either finasteride or doxazosin alone.