TY - JOUR
T1 - NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy
T2 - Results of a 52-week open-label study
AU - Simpson, David M.
AU - Brown, Stephen
AU - Tobias, Jeffrey K.
AU - Vanhove, Geertrui F.
AU - Martin, Mollen
AU - Sampson, James
AU - Gazda, Suzanne
AU - Brand, David
AU - Cutler, Barry
AU - Clifford, David
AU - Colson, Amy
AU - Ellis, Ronald
AU - Drusano, George
AU - Valcour, Victor
AU - Borkert, Claire
AU - McComsey, Grace
AU - Bartt, Russell
AU - De Jesus, Edwin
AU - Morris, Ann
AU - Myers, Robert
AU - Teinhart, Corklin
AU - So, Yuen
AU - Berger, Joe
AU - Hall, Colin
AU - McArthur, Justin
AU - Rubin, Michael
AU - Tselis, Alex
AU - Castro, Jose
AU - Rider, Dean
AU - Brinson, Cynthia
AU - Artin, Harold
AU - Pierone, Gerald
AU - Diaz, Leslie
PY - 2014/2
Y1 - 2014/2
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.
AB - 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.
KW - HIV-DSP
KW - capsaicin
KW - neuropathic pain
UR - http://www.scopus.com/inward/record.url?scp=84892951285&partnerID=8YFLogxK
U2 - 10.1097/AJP.0b013e318287a32f
DO - 10.1097/AJP.0b013e318287a32f
M3 - Article
C2 - 23446088
AN - SCOPUS:84892951285
SN - 0749-8047
VL - 30
SP - 134
EP - 142
JO - Clinical Journal of Pain
JF - Clinical Journal of Pain
IS - 2
ER -