The FDA has accepted a New Drug Application for silodosin, a novel alpha1-adrenoreceptor antagonist, from Watson Pharmaceuticals, Inc., of Corona, Calif. Watson is seeking approval of silodosin for the treatment of BPH symptoms.
Silodosin was designed to decrease urinary resistance and improve dysuria associated with BPH. Clinical trials demonstrated that a once-daily 8-mg dose of silodosin given for 12 weeks provided significant relief of BPH symptoms compared with placebo, as measured by the International Prostate Symptom Score, the primary end point.
The drug also improved maximum urine flow and quality of life. Silodosin was originally developed by Kissei Pharmaceutical Co., Ltd., in Japan and licensed to Watson for the United States, Canada and Mexico.