Male erectile dysfunction is one of the more “embarrassing” health conditions for patients to discuss with their doctors, right up there with irritable bowel syndrome and urinary incontinence. But the fact remains that ED is a widespread health issue that affects millions of men in the U.S. and can cause significant psychological distress to sufferers. ED patients collectively spend billions of dollars per year to treat the disorder, as evidenced by the blockbuster status of Viagra, Cialis and Levitra.
A disorder frequently associated with ED is Peyronie’s disease, characterized by the development of inflammation and hardened lumps of “plaque,” or scar tissue, within the penis. The scar tissue is benign but can cause the penis to bend during erection, leading to pain and psychological distress in patients. The precise cause of Peyronie’s disease has not been determined, although it is believed that genetics or trauma plays a role. Peyronie’s disease is most common in men over age 50.
Patients are typically treated with medication, injections (typically using the hypertension and angina drug verapamil), or, in severe cases, surgery. However, there are few pharmaceutical treatment options, and surgery can cause loss of sensation and shortening of the penis. Companies such as Auxilium Pharmaceuticals of Malvern, Penn., are working to find new, effective treatments for Peyronie’s patients. Auxilium announced Monday that it had dosed the first patient in a Phase III clinical trial of Xiaflex to treat Peyronie’s disease.
Xiaflex is injected into the affected area of the penis with the goal of softening the scar tissue and reducing the curvature of the penis. Two earlier Phase II studies of Xiaflex showed promising results, with 67 percent of patients showing significant improvement in one of the studies. Auxilium announced Tuesday that it had been granted a patent protecting purified collagenase, the active ingredient in Xiaflex. With the new patent, Xiaflex has patent protection through 2028. The Company also announced that it had filed additional patents with the U.S. Patent and Trademark Office that may expand the scope of patent claims covering Xiaflex. Auxilium currently markets a drug for low testosterone and is developing treatments for Dupuytren’s contracture and frozen shoulder syndrome. The Company is also developing a transmucosal drug delivery system based on a small film that adheres to the upper gum.
Other companies working in this space include Physion, based in Italy. Physion has patented the EMDA (Electromotive Drug Administration) system for the treatment of urological conditions including Peyronie’s disease. The EMDA system utilizes the process of iontophoresis, which involves using low-level electric current to deliver drugs through the skin—in this case, with the goal of softening the scar tissue. In previous studies, over 66 percent of Peyronie’s disease patients experienced a reduction in plaque volume, reduction of penile curvature, and elimination of pain from the administration of verapamil through EMDA.
PDLabs has developed a Transdermal Verapamil 15% Gel for connective tissue disorders such as Peyronie’s disease and Dupuytren’s disease. The gel is formulated to minimize absorption into the bloodstream while maximizing the drug’s concentration in affected area. PDLabs, a compounding pharmacy based in San Antonio, Texas, is the only place that can fill prescriptions for Transdermal Verapamil 15% Gel. The gel has been prescribed to more than 13,000 patients since 1998.
For readers who want to learn more about Peyronie’s disease, Peyronies.org has in-depth information on the causes, diagnosis and treatment of the disease.