Urology Product Preview

FDA accepts NDA for 6-month GnRH agonist formulation

FDA has accepted for review the supplemental new drug application of a new 6-month 45-mg formulation of leuprolide acetate (Lupron Depot) for the palliative treatment of prostate cancer.

Manufacturer Abbott Laboratories' submission was supported by new data from a 48-week study involving 300 patients with prostate cancer. Patients received two injections, 24 weeks apart, and were followed for nearly 1 year to evaluate efficacy and safety. Overall, testosterone suppression was sustained in patients throughout the treatment period.

ProUroCare Medical Inc. (Minneapolis) recently announced that it received a letter from FDA regarding its pending 510(k) premarket application for the company's ProUroScan prostate imaging system. The letter indicated that FDA could not complete its review because it believed an appropriate predicate device had not been identified.

If the ProUroScan system is not found to be substantially equivalent because a suitable predicate cannot be identified, FDA may indicate that the product may be appropriate for a "de novo" or "risk-based" classification. Information supporting such an application would then be combined with the previously submitted 510(k) application and re-submitted to FDA for review.

The ProUroScan is used to map abnormalities of the prostate detected by digital rectal exam.

Bladder management system cleared for clinical study

FDA has granted investigational device exemption (IDE) approval for the Surinate bladder management system, according to its manufacturer, Urovalve (Newark, NJ).

The Surinate system is designed to improve quality of life for men who suffer from acute or chronic urinary retention. The IDE approval allows Urovalve to conduct a clinical study of the device.

Pharmaceutical companies sign agreement for nocturia treatment

Allergan, Inc., and Serenity Pharmaceuticals, LLC, recently announced a global agreement for the development and commercialization of Ser-120, a phase III investigational drug currently in clinical development for the treatment of nocturia.

Under the terms of the agreement, Allergan receives exclusive worldwide rights to develop, manufacture, and commercialize Ser-120. The agreement encompasses all potential indications except primary nocturnal enuresis.

Loyola commences botulinum toxin study for urge incontinence

A new study under way at Loyola University Health System, Chicago, will compare botulinum toxin A to common oral medications for the treatment of female urge incontinence.

The study will evaluate the efficacy and cost-effectiveness of each treatment strategy as measured by the change in urge incontience episodes over 6 months. One group of women will receive botulinum toxin and another will receive traditional oral medication. Adult women must have five or more urge incontinence episodes in a span of 3 days in order to be considered eligible for the study.