Urology Product Preview March 2014

FDA may allow ED agent’s label to include on-demand data

The FDA has accepted a supplemental application that proposes to revise prescribing information for avanafil (STENDRA) with efficacy and safety information from study TA-501, which evaluated avanafil as an on-demand treatment for men with erectile dysfunction. The Prescription Drug Fee User Act date for the supplemental filing is Sept. 20, 2014. In the study, patients taking avanafil achieved statistically significant improvement versus placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes for the 200-mg dose and 12 minutes for the 100-mg dose following administration, according to VIVUS, the drug’s developer. The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity. Auxilium Pharmaceuticals has exclusive marketing rights to avanafil in the U.S. and Canada.

Target events reached in phase III trial of prostate cancer agent

The pre-specified number of events required for final analysis of the phase III SYNERGY trial of the investigational agent custirsen has been reached, OncoGenex Pharmaceuticals, Inc. recently announced. The primary efficacy endpoint of SYNERGY will analyze overall survival benefit for custirsen in combination with standard first-line docetaxel (Taxotere) chemotherapy and prednisone in men with metastatic castrate-resistant prostate cancer. Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis, OncoGenex said.

New drug application submitted for kidney transplant agent

Veloxis Pharmaceuticals has submitted a new drug application to the FDA seeking approval for the marketing and sale of once-daily tacrolimus (Envarsus; formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company’s clinical development program that comprised 25 studies and enrolled more than 1,000 patients, including two pivotal clinical trials, studies 3001 and 3002.

Prostate cancer test completes phase of clinical validation study

OPKO Health, Inc. has successfully completed the calibration confirmation phase of the 4Kscore test clinical validation study currently under way at 21 urology clinics in the United States. The OPKO 4Kscore test is a blood test that measures the serum levels of four different prostate-derived kallikrein proteins: total PSA, free PSA, intact PSA, and hK2. The results confirmed the validity of the algorithm. The study is now more than 50% complete toward the final goal of 1,200 subjects. These results support the U.S. launch of the 4Kscore test in March 2014, OPKO Health said.

Clinical study evaluates primary hyperoxaluria treatment

Oxthera AB has initiated a placebo-controlled trial of its oral agent Oxabact for the treatment of primary hyperoxaluria. Oxabact is composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes). Primary hyperoxaluria is a rare genetic disorder leading to elevated levels of endogenous oxalate in plasma and urine. High levels of urinary oxalate cause kidney damage, including stone formation.UT

Like this article? Check out other recent installments of Product Preview:

Urology Product Preview February 2014

Urology Product Preview November 2013

Urology Product Preview September 2013

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