Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia

A Randomized, Double-Blind, Placebo Controlled, Two-Way Cross-Over Study of Analgesic Efficacy of Bupivacaine Transdermal Therapeutic System in Patients With Post-Herpetic Neuralgia

Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may become dormant in the nervous system and later reactivate causing herpes zoster, also known as "shingles". Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin lesions. This study will test the safety and efficacy of treating PHN patients with the analgesic patch, Bupivacaine TTS (Eladur™).

Inclusion Criteria:

• Male or females age 21 years or older.
• Pain in thoracic or lumbar regions for a minimum of 90 days after crusting of Herpes Zoster (HZ) lesions.
• Stable prescribed medications regimen (including opioids, anticonvulsants, and tricyclic antidepressants).
• Intact, unbroken skin over the painful area to be treated.
• Body Mass Index (BMI) no more than 35 kg/m2.

Exclusion Criteria:

• Active HZ lesions, dermatitis, Central Nervous System (CNS) injury.
• Any immunosuppressed condition, including but not limited to AIDS/HIV and Hodgkin's lymphoma.
• Pain control by nerve block or neurosurgical intervention.
• Evidence of clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine or cardiovascular system abnormalities, psychiatric disorders, or acute infection.
• Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease).
• Recent use (within 30 days preceding the first treatment visit) of any topically applied pain medication, such as nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
• Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Patients must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
• Participation in a clinical trial of an investigational product or device within 30 days of the screening visit or concurrently during the conduct of this study.