Erectile Dysfunction Treatment Xiaflex Straightens Deformed Erections
For men who suffer from a special type of erectile dysfunction, there is a new drug for making sex and life just a little bit better. When an otherwise working erection takes an unusual and painful wayward bend in the wrong direction, two studies report that treatment with Xiaflex significantly reduces this penile curvature deformity. The reported current successful treatment of ED with Xiaflex and its past approval for treatment of Dupuytren's contracture, has motivated the FDA to announce its inclusion of a second approval for this drug to be used to treat patients with a special type of erectile dysfunction that affects at least an estimated 1 out of every 100 men.
The main symptom of this special type of erectile dysfunction is due to a medical condition first described by Francois Gigot de la Peyronie in 1743 and subsequently named “Peyronie’s disease” in his honor. Peyronie’s disease is a penile deformity that is caused by the buildup of palpable scar tissue called “penile plaques” that can develop on the top, bottom or the sides of the male external sex organ. In mild cases, plaque formation is localized to one area and results in “a bend” to one side or the other, or up or down. For a fortunate few, approximately between 5%-19% of the time, men with milder forms of Peyronie’s disease will resolve spontaneously without a permanent bending deformity.
In more severe cases, the plaque formation can encompass the entire girth and lead to what is referred to as a "waisting" or "bottleneck" deformity. In almost all cases there is significant pain or discomfort both physical and emotional that can make sex difficult and result in ED. Scarring can also cause shrinkage or significant shortening of the penile length.
In some cases, Peyronie’s disease is remedied by a surgical technique called the “Nesbit plication” where the tissue on the unaffected side of the penis is “cinched up” to create a straighter—but shorter—member.
While the cause of Peyronie’s disease is largely unknown, it has been associated with cases of physical trauma to the sex organs and aging due to a decreased ability to heal properly. The penis is divided into two soft tissue chambers called the corpora cavernosa that fills with blood during arousal and typically leads to a hardened erection. An area referred to as a septum between the two chambers can be damaged by physical trauma―such as a blunt force blow from a kick or accidental violent bending during sex―and manifest as bleeding with bruising that may result in formation of scarring. This scarring can then reduce the flexibility of the otherwise soft tissue and lead to abnormal curvature that can interfere with sex.
There is a genetic component to Peyronie’s disease that remains less definitive and has been reported in multiple generations. However, it is known that people who suffer from Dupuytren's contracture have an increased risk of developing erectile dysfunction via penile plaque formation.
Xiaflex was originally approved to treat Dupuytren's contracture―a progressive hand condition that inhibits your ability to move or straighten your fingers. Dupuytren's contracture is caused by an abnormal buildup of collagen that can build and thicken into rope-like cords in your palms that can then cause one or more of your fingers to bend toward the palm and eventually prevent fingers from being able to return to a straightened position. Collagen is an important structural protein in human tissue; however, abnormal amounts of collagen can lead to health complications.
Xiaflex is made from a living bacterial organism called Clostridial histolyticum of which a special protein enzyme called “collagenase” is extracted and used as the primary ingredient in Xiaflex. Xiaflex injection treatment works toward reversing the collagen buildup of Dupuytren's contracture by essentially dissolving the abnormal collagen cord buildup from the disease. In 2010, Xiaflex was approved by the FDA as the first nonsurgical treatment of Dupuytren's contracture and is still in use today for this special subset of patients. And now, a new subset of patients―albeit for a different extremity.
Like the hand, the external male sex organ contains collagen as one of its several tissue supporting proteins. The significance of this is that in men with Peyronie’s disease―with a penile curvature of at least 30 degrees―treatment with Xiaflex appears to reverse deformed erections by apparently breaking down collagen buildup involved in the curvature deformity. In other words, Xiaflex straightens out bent erections resulting in a resolving of this special type of erectile dysfunction and thereby improving a man’s sex life.
“Today’s approval expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option,” states Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.
This statement follows the reported success in two randomized double-blind, placebo-controlled studies involving 832 men with Peyronie’s disease who possessed a penile curvature deformity of at least 30 degrees.
In the studies, the men were divided into two groups where either Xiaflex or a placebo was injected directly into their penis twice during each session of a treatment plan that consisted of 4 separate sessions. What the researchers found was that the injections containing Xiaflex significantly reduced the amount of curvature in patients with deformed erections. Common adverse reactions associated with the Xiaflex injections included penile bruising, swelling and pain.
Health authorities warn that Xiaflex should only be administered by a licensed and trained physician due to the increased risk of a serious adverse reaction that includes developing a penile fracture or other serious penile injury. Patients are also advised to be sure to tell the treating physician ahead of time if they use blood thinning medication such as aspirin, prasugrel hydrochloride (Effient®), clopidogrel (Plavix®) or warfarin sodium (Coumadin®).
If you suspect that you may have Peyronie’s disease or may have an abnormal penile bend with or without erectile dysfunction, you should consult with your physician where a physical examination and ultrasound or x-rays can be used to determine whether there is abnormal penile plaque scarring resulting in the angle of your erections.
Image Source: Courtesy of Wikipedia
Auxilium Pharmaceuticals, Inc.: Treatment for adults with Dupuytren's contracture
FDA announcement--FDA approves first drug treatment for Peyronie’s disease