Urology Product Preview

April 1, 2010

New urology products and services on the horizon.

Patient enrollment completefor phase III trial of OAB gel

Antares Pharma Inc. recently announced that enrollment is complete for the double-blind portion of its phase III clinical trial of transdermal oxybutynin gel (Anturol) for treatment of overactive bladder.

The trial, which is being conducted under a special protocol assessment from FDA, is designed to evaluate the efficacy and safety of oxybutynin gel when administered topically, once daily for 12 weeks, in patients predominantly with urge incontinence episodes for at least 3 months. The primary endpoint is efficacy versus placebo, defined as reduction in the number of urinary incontinence episodes experienced per week. Data from the trial are expected in the third quarter of 2010.

FDA's Cardiovascular and Renal Drugs Advisory Committee recently voted to recommend approval of belatacept, an investigational selective co-stimulation blocker for the prophylaxis of acute rejection in de novo kidney transplant patients, according to Bristol-Myers Squibb, the drug's manufacturer.

The committee based its recommendation on a review of data from one phase II study and two phase III studies of belatacept that involved 1,000 patients.

Advanced prostate cancer agent moves into phase II clinical trial

Kinex Pharmaceuticals recently opened a phase II clinical trial of KX2-391 for patients with bone-metastatic, castrate-resistant prostate cancer who have not had prior chemotherapy.

The multicenter, single-arm study will enroll approximately 50 patients with progressive prostate cancer who will receive KX2-391 orally, twice daily for 24 weeks. The study's primary endpoint is to determine the number of patients who do not have clinical or radiographic progression after 24 weeks of treatment.

510(k) application submittedfor prostate Ca imaging system

ProUroCare Medical Inc. (Minneapolis) has filed a 510(k) application with FDA for U.S. market clearance of its prostate mechanical imaging system. The system can be used to help visualize and document abnormalities of the prostate that are detected and/or monitored by digital rectal examination, according to its labeling claim.

In November, ProUroCare said FDA had 90 days to review the application, although inclement weather in Washington in February has delayed processing of applications.

Statement revised for fertility-preserving hypogonadism agent

Repros Therapeutics Inc. has sent a revised indication statement to FDA's Division of Reproductive and Urologic Products for the use of enclomiphene (Androxal) for fertility preservation in men who are being treated for hypogonadism. FDA requested the statement during a Type C meeting held on Jan. 25, 2010.

Repros Therapeutics also provided a literature review of enclomiphene, as well as the final clinical study report investigating the drug's impact compared to a topical testosterone in men previously treated with testosterone.