Benign prostatic hyperplasia treatment did not meet trial goals, company says
QUEBEC CITY An investigational drug didn’t work much better than placebo in treating patients with benign prostatic hyperplasia, the drug’s developer announced Monday.
Drug maker ?terna Zentaris announced results of phase 3 efficacy and safety trials of the drug centrorelix pamoate, which the company had agreed to develop, register and market with Sanofi-Aventis U.S. in March.
In the 52-week efficacy trial, conducted at 61 sites in the United States, Canada and Europe, the drug showed “no clear differences in overall efficacy” between patients in the study and placebo groups. Results were measured based on the International Prostate Symptom Score. Nevertheless, there was a slight improvement up to the 46th week among the group that received the drug only, without the placebo, though improvements largely disappeared by the 52nd week.
In the 26-week safety trial, conducted at 68 sites in the United States and Canada, the drug was well-tolerated, with negative side effects mostly mild and transient; serious side effects were recorded in 12 patients, but there was no evidence they were related to use of the drug.
BPH, one of the most common diseases among aging men, affects more than 20 million men in the United States.