• Lynn R Webster, John F Peppin, Frederick T Murphy, Biao Lu, Jeffrey K Tobias, and Geertrui F Vanhove.
• Lifetree Clinical Research and Pain Clinic, Salt Lake City, UT, USA. lynnw@lifetreeresearch.com
• Diabetes Res. Clin. Pract. 2011 Aug 1;93(2):187-97.

AimsTo assess efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in patients with peripheral neuropathic pain.MethodsThis open-label, uncontrolled, 12-week study enrolled 25 patients with postherpetic neuralgia (PHN), one with HIV-distal sensory polyneuropathy, and 91 with painful diabetic neuropathy (PDN). Patients received pre-treatment with one of three 4% lidocaine topical anesthetics (L.M.X.4¹, Topicaine Gel², or Betacaine Enhanced Gel 4³) followed by a single 60- or 90-min NGX-4010 application. The primary efficacy variable was the percentage change in Numeric Pain Rating Scale scores from baseline to Weeks 2-12. Adverse events (AEs), laboratory parameters, vital signs, neurosensory examinations, dermal assessments, treatment-related pain scores, and medication use for treatment-related pain were collected.ResultsPDN and PHN patients achieved a 31% and 28% mean pain decrease from baseline during Weeks 2-12, respectively, and 47% and 44%, respectively, were responders (≥30% pain decrease). Mild or moderate treatment-site-related burning and pain were the most common AEs and there was no evidence of impaired neurosensory function.ConclusionsNGX-4010 in conjunction with any of the three topical anesthetics tested was generally safe and well tolerated and reduced pain over a 12-week period in patients with PDN and PHN.Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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