Urology Product Preview

August 1, 2011

Urology drugs and devices that are in the pipeline from Amgen, VIVUS, Pfizer, Palatin Technologies, Inc., and IsoRay Inc.

Application submitted to extend indication of prostate Ca treatment

Amgen has submitted a supplemental biologics license application to the FDA to expand the indication for denosumab (XGEVA) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If the application is approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The submission is based on a pivotal phase III study that demonstrated that denosumab significantly prolonged bone metastasis-free survival by more than 4 months compared to placebo in men with castrate-resistant prostate cancer that had yet spread to bone.

New drug application filed for erectile dysfunction agent

Following the successful completion of a phase III program, VIVUS announced the submission of a new drug application to the FDA for avanafil, an investigational drug for the treatment of erectile dysfunction.

In a recently completed phase III program of over 1,350 patients, avanafil was shown to be well tolerated and effective in men with ED.

According to VIVUS, avanafil demonstrated efficacy in patients as quickly as 15 minutes following dosing. There were no drug-related serious adverse events reported in any of the studies of the drug, the company said.

FDA accepts filing for review of renal cell carcinoma treatment

The FDA has accepted Pfizer's filing for a standard review of axitinib for patients with renal cell carcinoma. The submission was based on phase III trial data, which researchers recently presented at the American Society of Clinical Oncology annual meeting.

Axitinib is an investigational oral and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3.

Enrollment begins in trial of female sexual dysfunction treatment

Palatin Technologies, Inc. has begun enrolling women in a phase IIb trial of bremelanotide (previously PT-141), an on-demand melanocortin agonist being developed for the treatment of female sexual dysfunction. The trial will evaluate the agent's efficacy and safety.

The multicenter study is a placebo-controlled, randomized, parallel-group, dose-finding trial that will test three dose levels of subcutaneously administered bremelanotide in premenopausal women diagnosed with female sexual arousal disorder and/or hypoactive sexual desire disorder.

Dual-therapy study launched for high-risk prostate cancer treatment

IsoRay Inc. has announced a dual-therapy study using Cesium-131 brachytherapy and external beam radiation to examine the efficacy of combining intensity-modulated radiation with Cesium-131 brachytherapy to treat intermediate- and high-risk early-stage prostate cancer.

The study is expected to show that combining the two therapies will enhance treatment by lowering the required dosage of both applications, resulting in improved outcomes and potentially lessening side effects normally associated with prostate cancer treatments.