FDA approves Avodart/tramsulosin combination for prostate

PHILADELPHIA The Food and Drug Administration has approved GlaxoSmithKline’s enlarged prostate and acute urinary retention drug Avodart in combination with tamsulosin, the active ingredient in the Boehringer Ingelheim and Astellas Pharma prostate drug Flomax, for the treatment of symptomatic enlarged prostate.

The FDA approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate. The CombAT study is the first long-term assessment of the combination of Avodart and an alpha-blocker. The CombAT study results showed that combination therapy with Avodart and tamsulosin was superior to both monotherapies at one year and continued to year two.

“The combination of Avodart and tamsulosin at diagnosis allows doctors to simultaneously treat the patient’s prostate on two fronts by reducing prostate size and rapidly improving symptoms,” said Steven Kaplan, of Weill Cornell Medical College of Cornell University in New York City.