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Date: Jan 23 2012

Tolerability of NGX-4010 in conjunction with topical anesthetic formulations for the treatment of neuropathic pain.

Background: The objective of this study was to assess the safety, tolerability, and preliminaryefficacy of NGX-4010, a capsaicin 8% patch, following pretreatment with three different topicalanesthetics in patients with peripheral neuropathic pain.

Methods: This open-label, multicenter study enrolled 117 patients with post-herpetic neuralgia,HIV-associated distal sensory polyneuropathy, or painful diabetic neuropathy.Patients received pretreatment with one of three lidocaine 4%-based topical anesthetics(L.M.X.4® [Ferndale Laboratories Inc, Ferndale, MI], Topicaine® Gel [Estela Basso, Jupiter,FL], or Betacaine Enhanced Gel 4 [Tiberius Inc, Tampa, FL]) for 60 minutes followed by asingle 60- or 90-minute NGX-4010 application, and were followed for 12 weeks. Tolerabilityand safety measures included "pain now" Numeric Pain Rating Scale (NPRS) scores, dermalassessments, medication use for treatment-related pain, adverse events (AEs), clinical laboratoryparameters,physical examinations, and vital signs. The primary efficacy variable was thepercentagechange in mean NPRS scores for "average pain for the past 24 hours" from baselineto weeks 2 through 12.

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