Xiaflex to treat curved penis (Peyronie’s disease) found safe in studies: Auxilium

Xiaflex, an experimental drug to treat penile curvature, has shown better safety and efficacy profile in crucial phase IIb trial.

Xiaflex, which is being developed by Auxilium Pharmaceuticals, Inc contains collagenase clostridium histolyticum to treat penile curvature or Peyronie’s disease.

Xiaflex phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients’ sexual quality of life.

Xiaflex demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvature.

Xiaflex was well-tolerated and the most common treatment related adverse events in the phase IIb study were consistent with adverse events reported in previous Peyronie’s disease trials with Xiaflex, which included injection site bruising, edema and pain.

“We expect to meet with the FDA in the second quarter of 2010 to discuss a proposed phase III plan that potentially could be started in the second half of 2010,” stated Armando Anido, Auxilium’s chief executive officer and president.

The Xiaflex Peyronie’s disease phase IIb trial is one of the largest prospective, randomized, placebo-controlled studies conducted in Peyronie’s disease. A total of 145 patients evaluable for efficacy enrolled in 12 clinical sites across U.S., with 109 patients receiving Xiaflex as a series of intralesional injections and 36 receiving placebo in the study. The treatment and placebo arms were also randomized to test for a benefit with the addition of penile modeling versus no modeling. Modeling refers to massaging of the plaque and is intended to maximize the enzymatic effect of the Xiaflex injection in the plaque.

“Xiaflex has shown a sustained benefit at 36 weeks versus placebo for patients suffering from Peyronie’s disease,” said Laurence A. Levine, MD, FACS, investigator and Professor, Department of Urology, Rush University Medical Center. “The drug had a statistically significant reduction in penile curvature and demonstrated statistically significant improved quality of life for patients as measured by the PRO domain for Peyronie’s disease bother. Getting these efficacy results without the risks of surgical intervention would be an enormous advantage for patients suffering from Peyronie’s disease.”

Auxilium plans to have an end of phase II meeting with US FDA to discuss the validation of the PRO, phase IIb clinical results and phase III clinical trial design for Xiaflex for the treatment of Peyronie’s disease, in the second quarter of 2010.

Auxilium and its European partner Pfizer plan to request a meeting to discuss phase IIb results with European health authorities. Xiaflex is partnered with Pfizer in 46 European and Eurasian countries for the treatment of Dupuytren’s contracture and Peyronie’s disease. Auxilium is responsible for executing the global development program of Xiaflex for the treatment of Peyronie’s disease.

The trial measured the improvement in penile curvature and complete the validation of the Company’s proprietary Peyronie’s disease PRO, which measured four domains of patients’ sexual quality of life over a period of 36 weeks: penile pain, Peyronie’s disease bother, intercourse discomfort and intercourse constraint.

What is Peyronie’s disease?

Peyronie’s disease is the development of collagen plaque, or scar tissue, on the shaft of the penis that hardens and reduces flexibility, thus causing pain and forcing the penis to bend or arc during erection. This often can prevent sexual intercourse. In addition to difficulty with sexual intercourse, Peyronie’s disease may also be associated with emotional distress, loss of self-esteem and depression.

Peyronie’s disease is a very heterogeneous disease with an initial inflammatory component of a poorly understood physiological disease course and occasional spontaneous resolutions of 13% to 50% . In certain populations, the estimated number of men affected by Peyronie’s Disease may be as high as nine percent in men over 60 years of age and three percent in men over 30.

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians.

Auxilium markets Testim 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team.

Auxilium has five projects in clinical development. Xiaflex (collagenase clostridium histolyticum), formerly referred to as AA4500, has completed phase III clinical trials for the treatment of Dupuytren’s contracture, and the biologics license application is under review at the FDA for the treatment of Dupuytren’s contracture.

Xiaflex is in phase IIb of development for the treatment of Peyronie’s disease and is in phase II of development for treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium’s transmucosal film product candidate for the treatment of overactive bladder (AA4010) and its fentanyl pain product using its transmucosal delivery system are in phase I of development. Auxillium is currently seeking a partner to further develop these product candidates.