PDLabs
19230 Stone Oak Parkway , Suite 200
San Antonio, TX 78258
phone: 210-494-1678
fax:
Symbol Private
Founded 0
Employees
www.pdllabs.net
Research Sector
Summary Description
Transdermal gel for treatment of connective tissue disorders, including Peyronie's disease, Dupuytren's disease, and plantar fibromatosis
Management
Jerry Easterling, CEO
Keywords
urology, orthopedics, podiatry

Comment | Printable Version | Jul. 21, 2008
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Description
PDLabs, a compounding and research pharmacy established in 1998, specializes in research and development of new indications for existing medications and of new drug delivery systems. Its primary product in pharmacotherapy treats a variety of non-cancerous, fibrotic tissue disorders/wound healing disorders, such as Peyronie's disease, Dupuytren's disease, and plantar fibromatosis.
Products / Services
PDLabs has developed and patented the Transdermal Verapamil 15% Gel, a painless and non-invasive treatment for fibrotic tissue disorders. The gel, a prescription- compounded medication applied directly to the skin twice a day, is designed to carry Verapamil through the skin and to deliver this medication to an area of excess collagen (or plaque, as it is known in Peyronie's disease). The proprietary formula of the transdermal gel allows for minimal absorption into the blood while maximizing the concentration of Verapamil in the plaque and surrounding tissue.
Technology / Differentiation
Two different mechanisms of action have been proposed for the Transdermal Verapamil 15% gel. The first allows for delayed or halted lesion progression and the second allows for a reduced lesion, thus reducing or eliminating symptoms. Both processes are influenced by Verapamil's calcium channel blocking ability. Calcium channel blockers inhibit production of the fibrous tissue components collagen and fibronectin, as well as their release from cells known as fibroblasts (a calcium-mediated process). Studies have shown that calcium channel blockers also stimulate collagenase activity, an enzyme that breaks down excess collagen and potentially remodels lesions into healthy and elastic tissue.
Market / Customers
As of June 2008, 1.4 million people are currently managing Peyronie's disease (whose symptoms include painful erections and curvature of the penis) and the annual diagnosis rate is estimated at 3-9%. Plantar fibromatosis, characterized by pain when standing or walking due to firm, subcutaneous nodular masses on the bottom of the foot, is primarily diagnosed in the middle-aged and elderly populations (incidence among these groups is projected at 25%). Dupuytren's disease (a condition in which excess collagen forms lumps and/or indentations in the palms of one or both hands) currently has a global prevalence of 3-6%, with most cases in individuals of Northern European descent. Transdermal Verapamil 15% Gel has been prescribed for over 13,000 patients to date.
Status
PDLabs has received positive results from its clinical trials investigating the use of its gel to treat Peyronie's disease patients. In both its 57 patient double-blind placebo-controlled study and its 645 patient trial, the majority of patients experienced improved quality of erections, decreases in plaques and curvature, and complete erection pain relief. The company's plantar fibromatosis efficacy and safety study is currently in progress. Transdermal Verapamil 15% Gel was selected as a 'Top Ten Innovation in Podiatric Care' by Podiatry Today in its August 2007 product review. Plans are underway to obtain FDA approval of the gel for use in several indications.