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NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study.
Clin J Pain. 2014 Feb; 30(2):134-42.CJ

Abstract

OBJECTIVES

To evaluate the efficacy, safety, and tolerability of repeated NGX-4010 treatments in the open-label extension phase of a 52-week study in patients with neuropathic pain due to HIV-associated distal sensory polyneuropathy (HIV-DSP).

METHODS

Patients completing the 12-week, randomized, double-blind phase of the study could enter a 40-week, open-label phase, and receive up to 3, 60-minute NGX-4010 treatments. Patients recorded their "average pain for the past 24 hours" daily using the Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline to weeks 2 to 12 after the final treatment, and Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) questionnaires at study termination.

RESULTS

Of 307 patients randomized, 272 entered the open-label phase; 81, 90, 55, and 46 received 0, 1, 2, and 3 retreatments, respectively. The mean percentage decrease in NPRS score from baseline to weeks 2 to 12 after the final treatment was similar in patients receiving single or multiple NGX-4010 treatments (-25.8%, -27.1%, -24.6%, and -22.7% for 1, 2, 3, and 4 NGX-4010 treatments, respectively). PGIC and CGIC results demonstrated a benefit of NGX-4010 treatment through to the end of the study regardless of the number of treatments received. Transient local application site reactions were the most frequently reported adverse events, and were mainly mild to moderate, nonserious, and did not increase with repeated treatment.

DISCUSSION

Repeated NGX-4010 treatments were generally well tolerated and resulted in consistent reductions in HIV-DSP-associated pain and improvement in patient-reported outcomes.

Authors+Show Affiliations

*Clinical Neurophysiology Laboratories and Neuro-AIDS Program, Department of Neurology, The Mount Sinai Medical Center, New York, NY †AIDS Research Alliance, Los Angeles, CA ‡NeurogesX Inc., San Mateo, CA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23446088

Citation

Simpson, David M., et al. "NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy: Results of a 52-week Open-label Study." The Clinical Journal of Pain, vol. 30, no. 2, 2014, pp. 134-42.
Simpson DM, Brown S, Tobias JK, et al. NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. Clin J Pain. 2014;30(2):134-42.
Simpson, D. M., Brown, S., Tobias, J. K., & Vanhove, G. F. (2014). NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. The Clinical Journal of Pain, 30(2), 134-42. https://doi.org/10.1097/AJP.0b013e318287a32f
Simpson DM, et al. NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy: Results of a 52-week Open-label Study. Clin J Pain. 2014;30(2):134-42. PubMed PMID: 23446088.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. AU - Simpson,David M, AU - Brown,Stephen, AU - Tobias,Jeffrey K, AU - Vanhove,Geertrui F, AU - ,, PY - 2013/3/1/entrez PY - 2013/3/1/pubmed PY - 2014/8/29/medline SP - 134 EP - 42 JF - The Clinical journal of pain JO - Clin J Pain VL - 30 IS - 2 N2 - OBJECTIVES: To evaluate the efficacy, safety, and tolerability of repeated NGX-4010 treatments in the open-label extension phase of a 52-week study in patients with neuropathic pain due to HIV-associated distal sensory polyneuropathy (HIV-DSP). METHODS: Patients completing the 12-week, randomized, double-blind phase of the study could enter a 40-week, open-label phase, and receive up to 3, 60-minute NGX-4010 treatments. Patients recorded their "average pain for the past 24 hours" daily using the Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline to weeks 2 to 12 after the final treatment, and Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) questionnaires at study termination. RESULTS: Of 307 patients randomized, 272 entered the open-label phase; 81, 90, 55, and 46 received 0, 1, 2, and 3 retreatments, respectively. The mean percentage decrease in NPRS score from baseline to weeks 2 to 12 after the final treatment was similar in patients receiving single or multiple NGX-4010 treatments (-25.8%, -27.1%, -24.6%, and -22.7% for 1, 2, 3, and 4 NGX-4010 treatments, respectively). PGIC and CGIC results demonstrated a benefit of NGX-4010 treatment through to the end of the study regardless of the number of treatments received. Transient local application site reactions were the most frequently reported adverse events, and were mainly mild to moderate, nonserious, and did not increase with repeated treatment. DISCUSSION: Repeated NGX-4010 treatments were generally well tolerated and resulted in consistent reductions in HIV-DSP-associated pain and improvement in patient-reported outcomes. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/23446088/NGX_4010_a_capsaicin_8_dermal_patch_for_the_treatment_of_painful_HIV_associated_distal_sensory_polyneuropathy:_results_of_a_52_week_open_label_study_ L2 - http://dx.doi.org/10.1097/AJP.0b013e318287a32f DB - PRIME DP - Unbound Medicine ER -