title: NGX-4010, a high-concentration capsaicin dermal patch for lasting relief of peripheral neuropathic pain.
abstract: NeurogesX Inc is developing NGX-4010, a rapid-delivery dermal patch application system that contains high-concentration trans-capsaicin, for the treatment of peripheral neuropathic pain. Capsaicin evokes a lasting and reversible refractory state in primary sensory neurons involved in the generation and maintenance of neuropathic pain. NGX-4010 can be applied to the painful skin area up to a total surface area of 1120 cm2. In phase I clinical trials, NGX-4010 increased the threshold for warmth detection, reduced epidermal sensory nerve fiber density and was well tolerated. In phase II trials, NGX-4010 was effective in reducing pain in patients with post-herpetic neuralgia (PHN), HIV-associated distal sensory neuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). Data from phase III trials in patients with PHN demonstrated that significantly more pain relief was achieved by NGX-4010 (30 to 32% reduction from baseline) compared with a low-concentration capsaicin active control (20 to 24% reduction); however, only one of two studies involving patients with HIV-DSP met the primary endpoint. NGX-4010 appears to have the potential to be an effective adjunctive or a stand-alone therapy for PHN, as well as potentially for HIV-DSP and PDN. NGX-4010 has been granted approval by the European Commission and an NDA has been accepted for filing by the FDA.
authors: Mount Sinai School of Medicine, Department of Anesthesiology, New York, NY 10029, USA.
authors: Christopher
authors: C
authors: Noto
authors: Marco
authors: M
authors: Pappagallo
authors: Arpad
authors: A
authors: Szallasi
mesh_terms: D000279:Administration, Cutaneous; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000818:Animals; D002211:Capsaicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D015394:Molecular Structure; D009437:Neuralgia / Q000188:drug therapy*; D010330:Patents as Topic; D013329:Structure-Activity Relationship
chemical_list: D018712:Analgesics, Non-Narcotic; D015507:Drugs, Investigational; D002211:Capsaicin