Prostate Study Shows BOTOX May Be Safe, Effective Method for Managing Benign Prostatic H... ( DENVER April 27 -- Phase II data pre...)

Prostate Study Shows BOTOX May Be Safe, Effective Method for Managing Benign Prostatic Hyperplasia

Date:4/27/2009

DENVER, April 27 /PRNewswire-USNewswire/ -- Phase II data presented at the annual meeting of the American Urology Association (AUA) indicate that men suffering from an enlarged prostate may benefit from BOTOX(R) injections.

The two-stage, multi-center, double-blind, randomized study showed that two different dose levels of Botulinium Neurotoxin Type A (BOTOX) injected into the prostate was both safe and efficacious for the management of benign prostatic hyperplasia (BPH), a common noncancerous enlargement of the prostate that can cause difficulty in urination.

"People often underestimate the significant impact BPH can have on a man's quality of life," said Dr. E. David Crawford, one of the principal investigators of the study and head of the Urologic Oncology Department at the University of Colorado Health Sciences Center. "These data indicate that BOTOX is an effective, fast-acting treatment option that does not require daily dosage. We are excited to see what the long-term data will show us."

A renowned urologist and clinician, Dr. Crawford is a lead investigator on 17 abstracts presented at the AUA regarding both BPH and prostate cancer screening, including the prostate arm of the Prostate, Lung, Colorectal, and Ovarian (PLCO) study.

Study results included data from 125 men with BPH, aged 50 years and older, and treatment success was defined in terms of efficacy and safety over a 12 week timeframe. Patients were assigned to receive either 100 units or 300 units of BOTOX. Seventy-three percent of patients taking 100 units and 81 percent taking 300 units passed the cut offs for efficacy, defined as 30 percent or more improvement from baseline. Both doses also passed the safety criteria. Specifically, there were no grade four or five toxicity events observed in either dose, and only 17 percent in the 100 dose and 18 percent in the 300 dose reported grade two or three events
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