We are developing a transdermal bupivacaine patch (ELADUR) based on our proprietary TRANSDUR transdermal technology intended to provide continuous delivery of bupivacaine for up to three days from a single application, as compared to a wearing time limited to 12 hours with currently available lidocaine patches. We anticipate that ELADUR will have several potential differentiating attributes compared with currently marketed lidocaine patches, including extended duration of action and better wearability. We retain the worldwide commercialization rights to ELADUR.

Market Opportunity
A debilitating complication of herpes zoster is Post-Herpetic Neuralgia, which is usually defined as the presence of pain at the site of eruption that last more than a month after the onset of zoster eruption. Within the affected skin supplied by the nerve root, patients have a variety of sensory abnormalities in addition to neuropathic pain. Pain can persist for months and occasionally years.

Expected Product Benefits:

• Longer duration of action, as compared to the 12 hours of relief provided with currently available lidocaine patches;
• Fast onset time;
• Potentially deeper tissue penetration of bupivacaine versus lidocaine patches.

Current Clinical Status
This investigational drug is currently in Phase II clinical studies.

In 2007, we successfully completed a 60 patient Phase IIa clinical trial for ELADUR. In this study of patients suffering from PHN, ELADUR showed improved pain control versus placebo during the 3-day continuous treatment period. In addition, ELADUR appeared well tolerated overall, and patients treated with ELADUR and placebo exhibited similar safety profiles. We are currently conducting manufacturing scale-up and processing studies to secure additional Phase II and Phase III supplies, and are developing clinical and regulatory strategy.