1. 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
- Author
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David M. Simpson, Geertrui F. Vanhove, Colin D. Hall, Jose G. Castro, Gerald Pierone, Ann Morris, Jeffrey Tobias, Robert Myers, David Brand, Yuen T. So, Suzanne Gazda, Victor Valcour, Michael Rubin, Corklin Teinhart, Mollen Martin, Barry J Cutler, Russell Bartt, Justin C. McArthur, Stephen J. Brown, Dean Rider, Joe Berger, James Sampson, Cynthia Brinson, Harold Artin, Grace A. McComsey, Claire Borkert, Leslie Diaz, George L. Drusano, Ronald Ellis, Alex Tselis, David B. Clifford, Edwin De Jesus, and Amy Colson
- Subjects
Adult ,Male ,Sensory Receptor Cells ,Transdermal patch ,Endpoint Determination ,Transdermal Patch ,HIV Infections ,Kaplan-Meier Estimate ,law.invention ,chemistry.chemical_compound ,Patient satisfaction ,Randomized controlled trial ,Double-Blind Method ,law ,Medicine ,Humans ,Pain Management ,Adverse effect ,Pain Measurement ,Skin ,Neurologic Examination ,business.industry ,Peripheral Nervous System Diseases ,Middle Aged ,Dermal patch ,Anesthesiology and Pain Medicine ,Treatment Outcome ,Tolerability ,chemistry ,Capsaicin ,Patient Satisfaction ,Anesthesia ,Neuropathic pain ,Neuralgia ,Female ,Neurology (clinical) ,business - 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.
- Published
- 2013