Bayer to Launch Viadur: First Once-Yearly Dosing Regimen for Continuous Testosterone Suppression

28-May-2001

Bayer Corporation announced today that Viadur(leuprolide acetate implant), the first and only once-yearly implant for the palliative treatment of advanced prostate cancer, is now available in the U.S. Viadur offers patients 12-month, continuous testosterone suppression - an alternative to the one-, three-, or four-month injections currently in use.

Viadur is a titanium implant containing leuprolide acetate. The implant is inserted under the skin of the patient's upper arm during an in-office procedure. Viadur maintains steady serum leuprolide concentrations throughout the 12-month dosing period. For more than a decade in the U.S., leuprolide acetate has been the primary drug used in testosterone suppression therapy for the palliative treatment of advanced prostate cancer.

"Viadur was effective in suppressing testosterone below the castrate threshold. It also was generally well tolerated in open label clinical trials where 90 percent of patients chose to continue Viadur therapy for a second 12-month period," said James Gottesman, M.D., Clinical Professor of Urology at the University of Washington Medical School. "Viadur is an integral component of a comprehensive approach to patient management that includes regular follow-up for scheduled tests and examinations throughout the year."

Leuprolide belongs to a class of drugs known as luteinizing hormone-releasing hormone (LH-RH) agonists, which decrease the amount of testosterone produced by the body. Testosterone suppression therapy can provide symptomatic relief and slow the growth of cancer cells. Hormone therapy also may be administered to patients before or after radiation treatment or surgery.

"Viadur (leuprolide acetate implant) offers men 12 months of continuous hormone suppression therapy with one office procedure, providing them an important new alternative to the one-, three-, and four-month injections currently available," said Wolfgang Plischke, Ph.D., President of the North American Pharmaceutical Division of Bayer. "We believe Viadur may meet the varied needs and busy lifestyles of many patients today, including retirees who travel frequently, men still in the workplace, patients who live in rural areas, and those in long-term care facilities."

Plischke added that Viadur is part of the company's growing portfolio of men's health products. "Bayer has already established itself as a credible force in men's health with Cipro® (ciprofloxacin HCl) to treat bacterial prostatitis. We are currently conducting Phase III clinical trials of a drug under investigation to improve erectile function and hope to submit a new drug application later this year. As you can see, Viadur adds significantly to our focus on men's health," said Plischke.

Clinical Studies Testosterone suppression hormonal therapy is commonly used to relieve cancer symptoms and slow the growth of cancer cells. The goal is to lower levels of the male hormone testosterone, which is associated with a therapeutic response in most patients. In two open-label, multi-center studies, 131 patients with advanced prostate cancer were treated with Viadur and evaluated for up to two years. Following the initial surgical insertion of the implant, mean serum testosterone concentrations decreased to therapeutically desirable levels by week four in 99 percent of the patients in the studies. Once serum testosterone suppression was achieved, testosterone levels remained suppressed for the duration of the 12-month treatment phase.

https://www.chemeurope.com/en/news/3314/bayer-to-launch-viadur-first-once-yearly-dosing-regimen-for-continuous-testosterone-suppression.html