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Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain.
J Pain Symptom Manage. 2010 Jun; 39(6):1053-64.JP

Abstract

CONTEXT

Postherpetic neuralgia (PHN) and painful human immunodeficiency virus-associated distal sensory polyneuropathy (HIV-DSP) are peripheral neuropathic pain syndromes that are difficult to treat. Current treatment options are often limited by poor tolerability.

OBJECTIVES

The objective of the current open-label study was to assess the safety of repeated applications of NGX-4010, a high-concentration capsaicin patch (capsaicin 8%), over one year, in patients with moderate to severe PHN or HIV-DSP.

METHODS

Patients had successfully completed a previous NGX-4010 study and had a pain level appropriate for further treatment. Eligible patients had not been treated with NGX-4010 within 12 weeks of study initiation. Patients received pretreatment with a topical local anesthetic (lidocaine 4%) for 60 minutes followed by either a 60-minute (PHN and HIV-DSP patients) or a 90-minute (HIV-DSP patients) treatment with NGX-4010. Patients could receive up to three additional treatments at intervals of > or = 12 weeks. Regardless of the number of treatments received, all patients were followed up for 48 weeks except for those withdrawing early.

RESULTS

A total of 106 patients were enrolled and received a total of 293 NGX-4010 treatments. The most frequently reported treatment-emergent adverse events were transient, mild-to-moderate application site erythema, pain, edema, and papules. Small, transient pain-related increases in blood pressure during and immediately after NGX-4010 application were observed. There was no evidence of an increased incidence of adverse events, dermal irritation, intolerability, or impaired neurological function with repeated treatments.

CONCLUSION

It is concluded that repeated treatments with NGX-4010 administered over a one-year period are generally safe and well tolerated.

Authors+Show Affiliations

Department of Neurology, Mount Sinai School of Medicine, New York, New York 10029, USA. david.simpson@mssm.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20538187

Citation

Simpson, David M., et al. "Long-term Safety of NGX-4010, a High-concentration Capsaicin Patch, in Patients With Peripheral Neuropathic Pain." Journal of Pain and Symptom Management, vol. 39, no. 6, 2010, pp. 1053-64.
Simpson DM, Gazda S, Brown S, et al. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage. 2010;39(6):1053-64.
Simpson, D. M., Gazda, S., Brown, S., Webster, L. R., Lu, S. P., Tobias, J. K., & Vanhove, G. F. (2010). Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. Journal of Pain and Symptom Management, 39(6), 1053-64. https://doi.org/10.1016/j.jpainsymman.2009.11.316
Simpson DM, et al. Long-term Safety of NGX-4010, a High-concentration Capsaicin Patch, in Patients With Peripheral Neuropathic Pain. J Pain Symptom Manage. 2010;39(6):1053-64. PubMed PMID: 20538187.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. AU - Simpson,David M, AU - Gazda,Suzanne, AU - Brown,Stephen, AU - Webster,Lynn R, AU - Lu,Shiao-Ping, AU - Tobias,Jeffrey K, AU - Vanhove,Geertrui F, AU - ,, PY - 2009/05/07/received PY - 2009/10/17/revised PY - 2009/11/05/accepted PY - 2010/6/12/entrez PY - 2010/6/12/pubmed PY - 2010/9/10/medline SP - 1053 EP - 64 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 39 IS - 6 N2 - CONTEXT: Postherpetic neuralgia (PHN) and painful human immunodeficiency virus-associated distal sensory polyneuropathy (HIV-DSP) are peripheral neuropathic pain syndromes that are difficult to treat. Current treatment options are often limited by poor tolerability. OBJECTIVES: The objective of the current open-label study was to assess the safety of repeated applications of NGX-4010, a high-concentration capsaicin patch (capsaicin 8%), over one year, in patients with moderate to severe PHN or HIV-DSP. METHODS: Patients had successfully completed a previous NGX-4010 study and had a pain level appropriate for further treatment. Eligible patients had not been treated with NGX-4010 within 12 weeks of study initiation. Patients received pretreatment with a topical local anesthetic (lidocaine 4%) for 60 minutes followed by either a 60-minute (PHN and HIV-DSP patients) or a 90-minute (HIV-DSP patients) treatment with NGX-4010. Patients could receive up to three additional treatments at intervals of > or = 12 weeks. Regardless of the number of treatments received, all patients were followed up for 48 weeks except for those withdrawing early. RESULTS: A total of 106 patients were enrolled and received a total of 293 NGX-4010 treatments. The most frequently reported treatment-emergent adverse events were transient, mild-to-moderate application site erythema, pain, edema, and papules. Small, transient pain-related increases in blood pressure during and immediately after NGX-4010 application were observed. There was no evidence of an increased incidence of adverse events, dermal irritation, intolerability, or impaired neurological function with repeated treatments. CONCLUSION: It is concluded that repeated treatments with NGX-4010 administered over a one-year period are generally safe and well tolerated. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/20538187/Long_term_safety_of_NGX_4010_a_high_concentration_capsaicin_patch_in_patients_with_peripheral_neuropathic_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(10)00243-5 DB - PRIME DP - Unbound Medicine ER -