High-Strength Capsaicin Cream 0.25% in a Lidocaine-Containing Vehicle (Axsain™) Is a Safe and Effective Adjunctive Treatment for Painful Diabetic Neuropathy or Postherpetic Neuralgia

Abstract

AbstractA multi-center study was conducted to assess the clinical effectiveness and safety of high-strength capsaicin cream 0.25% in a lidocaine-containing vehicle for treatment of painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN). Eighty-three (83) patients with PDN (n = 56) or PHN (n = 27) who were already taking oral antiepileptics or tricyclic antidepressants with incomplete pain relief were enrolled. Capsaicin cream 0.25% in a lidocaine-con-taining vehicle was applied to painful areas three times daily for 6 weeks. Pain intensity was evaluated at Weeks 1,3, and 6 using an Average Weekly Pain Score. At Week 6, improvement was also assessed with a Subject Global Evaluation (SGE), a Physician Global Evaluation (PGE), and a Functional Assessment Questionnaire. Following 1,3, and 6 weeks of treatment, pain was reduced by 21%, 40%, and 50%, respectively, in patients with PDN, and by 24%, 39%, and 51%, respectively, in patients with PHN. On the SGE, 90% of patients with PDN were rated as Im...