Contact UsTransdermal Verapamil 15% Gel is a painless, non-invasive, treatment for fibrotic tissue disorders such as Peyronie's disease, plantar fibromatosis, and Dupuytren's disease that was developed and patented by PDLabs. Since 1998, PDLabs Transdermal Verapamil 15% Gel has been prescribed for over 13,000 patients. It is a prescription, compounded medication that is applied directly to the skin twice a day and is not FDA approved. Verapamil belongs to the class of medications known as calcium channel blockers. The gel has been designed to carry the verapamil through the skin and deliver it to the lesion. The proprietary formula allows for minimal absorption into the blood, while maximizing the concentration of verapamil in the lesion and surrounding tissue.
Minimal side effects and no risk of additional damage to healthy surrounding tissue, which is a risk normally characteristic of invasive treatments.
Daily localized application enables necessary drug concentration levels to be continually maintained in the affected tissue with little systemic absorption.
Application to the entire penile shaft or fascia allows both palpable and non-palpable fibrotic tissue to be treated, aiding in preventing reoccurrence and improving overall tissue characteristics.
The most important advantage to Transdermal Verapamil 15% Gel is that it is non-invasive. This eliminates the possibility of worsening the condition as can happen with invasive treatments.
Due to the density of the collagen, injection therapies such as verapamil, corticosteroid, interferon, and collagenase injections are unable to effectively diffuse medication throughout the entire lesion. Therefore, multiple injections must be made to attempt to diffuse the medication. This may cause additional trauma to the surrounding tissue and worsen the condition. In the comparision table below, an increase in Peyronie's plaque size is seen after injections and a reduction in plaque size is seen after treatment with Transdermal Verapamil 15% Gel. Additionally, since injection therapy only pinpoints the palpable lesion, any non-palpable plaque is left untreated, resulting in a less effective treatment.
Iontophoresis treatment, like injections, only pinpoints the palpable lesion. This leaves any non-palpable lesions untreated, resulting in a less effective treatment.
Surgery is often used to treat all three conditions but poses unique disadvantages. In Peyronie's disease, if a graph procedure is performed only the primary plaque is removed, any other fibrosis in the shaft is left untreated. Other procedures performed to straighten the shaft can lead to significant decrease in penile length and/or girth. Other risks that can be avoided with a non-invasive treatment include impotence or recurrence from the surgical scars. In plantar fibromatosis and Dupuytren's disease a high percentage of recurrence is seen when only a partial fasciotomy is performed due to the difficulty in removing all of the dysfunctional fibroblast. Complete fasciotomy requires a long recovery time and can lead to other complications.
Oral medications (Vitamin E, colchicine, para-amino benzoate (Potaba®), etc.) are unable to sufficiently concentrate in the affected fibrotic tissue due to systemic absorption and metabolization.
The most common side effect reported with Transdermal Verapamil 15% Gel, affecting 3-5% of Peyronie's disease patients, is varying degrees of skin irritation. Some patients using the medication for the first time may experience mild itching/irritation during the first few days of treatment. This is normal and usually resolves within 3-4 days. Other patients may experience more severe contact dermatitis, including itching, burning, redness, or swelling. More persistent or severe irritation can usually be treated with topical corticosteroids. Based on the individual symptoms, PDLabs will work with the patient and prescribing physician to determine the best course of treatment to resolve irritation. This side effect is not seen in plantar fibromatosis or Dupuytren's disease patients.
A PDLabs pharmacist reviews all medications and supplements taken by a patient before filling a prescription and informs the patient if there is risk of adverse drug reactions. The pharmacist also consults with the patients' cardiologist or other specialist regarding any safety issues involved with using verapamil if the patient has a history of questionable medical conditions.
Commonly used to treat hypertension and certain arrhythmias. This class of drugs, as noted in the Physician's Desk Reference, has been reported to cause tissue fibrosis. In addition, there are many references in published literature indicating a link between beta blockers and Peyronie's disease. These drugs may also hinder the effectiveness of Transdermal Verapamil 15% Gel. Patients placed on an alternative therapy for hypertension such as a calcium channel blocker or ACE Inhibitor may respond more favorably to Transdermal Verapamil 15% Gel.
Verapamil taken orally may interfere with the metabolism of these drugs, resulting in higher blood levels due to delayed drug metabolism and elimination. This can lead to an increased likelihood of experiencing muscle aches and/or pains and rhabdomyolysis. This is a possible side effect that occurs with statin therapy alone, but may be enhanced by using oral verapamil. Transdermal Verapamil 15% Gel is formulated to have minimal systemic absorbtion; however, the patient should be advised of this possible adverse effect.
These medications can hinder or inhibit the production of collagenase, thereby interfering with the mechanism of action necessary to remodel the lesion.
Connective tissue disorders have been listed as possible side effects of these drugs.
Patients taking digoxin/cyclosporin should have these drug levels monitored on a regular basis while using Transdermal Verapamil 15% Gel. Verapamil taken orally may decrease the metabolism and clearance rate of these drugs, possibly resulting in toxic levels. Transdermal Verapamil 15% Gel is formulated to have minimal systemic absorbtion; however, the patient should be advised of this possible adverse effect.
Tobacco use impedes the skin's ability to absorb topically applied medication by lowering the skin's temperature. Recently published studies have also implicated nicotine in the delay of wound healing.
Chondroitin sulfate is a glycosaminoglycan (GAG). It combines with keratan sulfate, dermatan sulfate and heparan sulfate, and accumulates in cartilage on cell surfaces and matrixes; it is widespread in connective tissues, and is found in the secretory vesicles in white blood cells and on fibroblast and epithelial cell surfaces. It provides mechanical support, helps to package and store secretory molecules, and functions in cell adhesion*. It also binds to Transforming Growth Factor Beta which, in excess, has been associated with Peyronie's disease. Chondroitin compounds also bind to Fibroblast Growth Factor (FGF) and to Type I collagen fibrils. PDLabs recommends patients discontinue this supplement when treating fibrotic tissue disorders with Transdermal Verapamil 15% Gel.
Excess ascorbic acid intake can promote excess collagen production since it is essential for the conversion of proline to hydroxyproline in the collagen production process. PDLabs recommends not taking more than 400mg of Vitamin C daily while being treated with Transdermal Verapamil 15% Gel.
As with many medications, the exact mechanism of action of Transdermal Verapamil 15% Gel is not entirely understood. It is proposed that two different processes are taking place. The first allows for the progression of the lesion to be slowed or stopped and second for the lesion to actually be reduced, which allows for the symptoms of the condition to be reduced or eliminated. Both of these processes are effected by verapamil's ability as a calcium channel blocker to block calcium.
Cells known as fibroblasts are responsible for the production of the primary components of the lesion such as collagen, fibronectin and glycosaminoglycans. Research has shown that the process by which these components are released out of the fibroblast requires calcium. It has been found that calcium channel blockers have the ability to decrease the production of collagen and fibronectin and their release from the fibroblast*. A study has also shown that the large increase of Peyronie's fibroblasts is markedly impaired by verapamil, even at low doses*. This research is the basis of why it is thought that using Transdermal Verapamil 15% Gel in the inflammatory or early stages of these fibrotic tissue disorders, may prevent the condition from being as severe as it might have been without any treatment*.
Fibroblasts are also responsible for the production of collagenase, which is responsible for remodeling the excess collagen that makes up the lesion. Research has demonstrated that calcium channel blockers such as verapamil have the ability to increase the activity of collagenase, which enhances the remodeling of scars in burn victims. It was also found in experiments with bovine fibroblasts that exposure to verapamil increased collagenase activity*. Peyronie's disease, plantar fibromatosis, and Dupuytren's disease are thought to be similar to other wound disorders such as keloids and hypertrophic scars*. Research on the use of verapamil in keloids has suggested that it may increase procollagenase production, meaning that verapamil may be capable of increasing collagen breakdown. Although this research was not done on fibroblasts from Peyronie's disease, plantar fibromatosis, or Dupuytren's disease, it is theorized that fibroblasts from these lesions will respond in a similar way*. This theory is supported by objectively measured improvements in Peyronie's disease plaque and plantar fibromatosis in clinical studies with Transdermal Verapamil 15% Gel. The increase in collagenase activity after exposing the fibroblasts to verapamil, helps to explain how Transdermal Verapamil 15% Gel can remodel an already formed and stable lesion into more healthy and elastic tissue. The remodeling of the tissue and return of the elasticity allows for the symptoms of the condition to be reduced or eliminated.
The illustration below shows the two proposed mechanisms of action, magnified to the level of the fibroblast.
