Despite the serious side effects, which include "penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury" the FDA just voted in favor of market approval of Auxilium's Xiaflex, soaring the AUXL stock within just minutes of approval, but probably not enough, perhaps on the news of Moody's downgrading it from "stable" to "negative" in relation to recent lawsuits involving Auxilium's Testim gel.
Xiaflex (Collagenase clostridium histolyticum) is an enzyme produced by the bacterium Clostridium histolyticum that dismantles collagen. It is marketed and is being developed as a local injection into areas with overly high collagen accumulation, such as in the case of Dupuytren’s disease (severely clenched fingers) and now Peyronie’s disease (penile curvature)—a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis affecting up to 10% of men. According to Auxilium, 65,000 to 120,000 new patients are diagnosed with Peyronie’s disease each year. Peyronie’s disease causes pain, abnormal curvature, erectile dysfunction, indentation, loss of girth and shortening.
In two 400-patient trials Xiaflex was injected into the penile plaque over a period of several months. The treatment yielded a 37.6 reduction in penile curvature in one trial and a 30.5% reduction in the second. The average deformity of the penis at the beginning of the study was 48.8 degrees in men receiving the drug and 49 degrees in those receiving placebo. After 52 weeks, the deformity was only 31 degrees in men receiving Xiaflex and 39 degrees in those receiving placebo.
According to the FDA, "[The Xiaflex] treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional."
The future of Xiaflex for this new indication is not yet certain. The total cost of treatment per patient is expected to be US$ 40,000, and there is no news yet on whether insurers are willing to cover the costs. In the case of Dupuytren's, for which Xiaflex is already approved, 95%+ of patients are reimbursed under common insurance schemes. For Peyronie's, at least 130 patients a year fit the "30 - 90 degree curvature" criteria of the ideal patient, utilized in the IMPRESS trial. The indication may be flexible. For those to whom the issue may seem cosmetic, roughly 52% of Peyronie's sufferers report erectile dysfunction and pain and are likely to really, really want the treatment.
The future of Xiaflex for this new indication is not yet certain. The total cost of treatment per patient is expected to be US$ 40,000, and there is no news yet on whether insurers are willing to cover the costs. In the case of Dupuytren's, for which Xiaflex is already approved, 95%+ of patients are reimbursed under common insurance schemes. For Peyronie's, at least 130 patients a year fit the "30 - 90 degree curvature" criteria of the ideal patient, utilized in the IMPRESS trial. The indication may be flexible. For those to whom the issue may seem cosmetic, roughly 52% of Peyronie's sufferers report erectile dysfunction and pain and are likely to really, really want the treatment.
Herbal remedies are safe to utilize and herbs provide a safe and effective for peyronie's disease herbal treatment. It is a combination of the natural ingredients that help you to get rid of this problem. This Herbal Supplements can be utilized. It helps in dissolving the scar tissue that is available around the penis. It additionally helps in reinforcing the muscles of the penis and builds the blood supply. For more info visit http://www.hashmidawakhana.org/penile-abnormality-curvature.html
ReplyDelete