Investigational BPH therapies yield promising results

October 9, 2008

Two investigational BPH therapies are yielding positive efficacy results in men with the condition, according to studies presented at recent AUA section meetings.

Two investigational BPH therapies are yielding positive efficacy results in men with the condition, according to studies presented at recent AUA section meetings.

Treatment with silodosin (RAPAFLO), an investigational selective alpha-1 adrenergic receptor antagonist, effectively reduces the symptoms of BPH and appears to be well tolerated without causing any significant changes in blood pressure or adverse cardiac effects, according to data presented at the AUA New England Section annual meeting in Rio Grande, Puerto Rico.

Two phase III double-blind, placebo-controlled trials included 923 generally healthy men ages 50 years or older with signs and symptoms of BPH, including a peak urine flow rate between 4 and 15 mL/sec and International Prostate Symptom Score (IPSS) ≥13 (mean, 21.3). Patients were randomized to either silodosin, 8 mg once daily, or placebo for 12 weeks.

After 12 weeks of treatment, silodosin significantly improved urinary symptoms, including IPSS (the primary endpoint), compared with placebo (mean reduction of -6.4 vs. -3.5, respectively; p<.0001). On secondary measures, silodosin improved Qmax scores both at 2 to 6 hours following the first dose (mean improvement of 2.8 mL/sec vs. 1.5 mL/sec for placebo; p<.0001) and after 12 weeks (mean improvement of 2.6 vs. 1.5 for placebo; p=.0007), according to a release from Watson Pharmaceuticals, which is developing silodosin.

In a separate study that was presented at the AUA South Central Section annual meeting in Santa Ana Pueblo, NM, treatment with a single dose of NX-1207, another BPH agent under study, significantly improved BPH symptom scores (p=.034) and significantly reduced prostate size (reduction of 4.90 grams, p=.013) after 90 days, reported Raphael Wurzel, MD, of Grove Hill Medical Center in New Britain, CT. Treatment was office-based, analgesic, anesthetic-free and did not require catheterization, according to Nymox Pharmaceutical Corp., the drug’s developer.

Blinded clinical trials to date have shown that men treated with NX-1207 reported statistically significant improvement in BPH symptoms 3 months after a single treatment with no reported serious drug-related side effects. In two multicenter phase II U.S. prospective, randomized, blinded clinical trials, the aggregated mean improvement in the primary endpoint of BPH symptom score for NX-1207, 2.5 mg, was 10.3 points, or a 44% improvement in symptom score.