June 2014 Urology Product Preview

FDA accepts pre-chemo application for PCa agent, grants priority review

The FDA has accepted for filing the supplemental new drug application to extend the indication for enzalutamide (XTANDI) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy, Astellas Pharma Inc. and Medivation Inc. announced. The application was granted priority review designation with an FDA Prescription Drug User Fee Act review date of Sept. 18, 2014. The application is based on the results of the phase III PREVAIL trial, which evaluated enzalutamide compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. For recent results of the PREVAIL trial, see article "Androgen inhibitor shows meaningful benefit pre-chemo."

Oral testosterone formulation found safe, tolerable in phase II study

TSX-002, a first-in-class oral formulation of unmodified testosterone, has been very well tolerated in a phase II study, with no liver toxicity, supraphysiologic testosterone levels, or HDL reduction observed to date, according to developer TesoRx. For the phase II study, all FDA endpoint guidelines have been achieved, and the agent was found to be safe and tolerable. The data readout of the trial was expected in June 2014, with commencement of a phase III study planned for the second half of 2014.

Positive phase I results reported for topical PDE-5 inhibitor

Strategic Science and Technologies recently announced positive phase I clinical results for its first-in-class topical sildenafil product candidate, SST-6006, for the treatment of erectile dysfunction. The agent was well tolerated in healthy subjects and successfully delivered sildenafil through the skin and into the local penile tissue, according to Strategic Science and Technologies. SST-6006 was also systematically absorbed into the bloodstream, but at significantly reduced levels compared to oral sildenafil. The company said it plans to initiate phase II trials this year.

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Urinary tract infection agent meets or exceeds non-inferiority margins

Cubist Pharmaceuticals, Inc.’s antibiotic candidate ceftolozane/tazobactam’s clinical cure and/or microbiologic eradication rates met or exceeded pre-specified FDA and European Medicines Agency non-inferiority margins in pivotal phase III clinical trials, the company reported. The agent is being developed for the treatment of serious infections, including complicated urinary tract infections and complicated intra-abdominal infections. Results from the trials were reported at the European Congress of Clinical Microbiology and Infectious Diseases in Barcelona, Spain.

Urine void tracking device in final stages of clearance for U.S. rollout

SCA’s continence care technology TENA Identifi is in the final stages of regulatory clearance for an introduction to the U.S. market, the company said in a press release. The device uses sensor technology to capture individual voiding patterns and provide more individualized continence planning and resident care in acute and long-term care facilities. Over a 72-hour assessment period, the TENA Identifi tracks voiding patterns and volume at each product change and then graphically converts the data into actionable, evidence-based reports.

Want more Urology Product Preview? Check out these previous installments:

May 2014 Urology Product Preview

April 2014 Urology Product Preview

March 2014 Urology Product Preview

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