FDAnews Drug Daily Bulletin

Avodart With Flomax Approved for Enlarged Prostate

June 30, 2008

The FDA has approved GlaxoSmithKline’s Avodart in combination with tamsulosin to treat enlarged prostate.

Clinical data show the two medicines together treat enlarged prostate symptoms more effectively than either one alone, according to GSK. The combination of Avodart (dutasteride) and tamsulosin (Flomax) reduces prostate size and improves symptoms.

Results from the CombAT study show that Avodart and tamsulosin together were superior out to 24 months. The study will continue for two more years to provide more data on the long-term outcomes for patients taking the combined drugs compared with those taking only one, GSK said.

Avodart is approved to treat urinary symptoms with enlarged prostate, reduce the risk of acute urinary retention and reduce the risk of prostate-related surgery. Tamsulosin is an alpha blocker indicated to treat signs and symptoms of enlarged prostate. Common symptoms include weak stream, incomplete bladder emptying, frequent and urgent urination, starting and stopping and the need to urinate during the night.

Avodart, a dual five-alpha-reductase inhibitor for the treatment of enlarged prostate, suppresses dihydrotestosterone (DHT) by 93 percent at two years, GSK said. DHT is the primary male hormone responsible for the enlargment of the prostate. Sales of Avodart were about $562 million in 2007, according to the company.