HIV-associated distal sensory
polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with
HIV infection.
NGX-4010 is a
capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze the efficacy and safety of
NGX-4010 and explore the effect of demographic and baseline factors on
NGX-4010 treatment in HIV-DSP.
METHODS: Data from two similarly designed studies in which patients with HIV-DSP received
NGX-4010 or a low-concentration control patch (
capsaicin 0.04% w/w) for 30 or 60 minutes were integrated. Efficacy assessments included the mean percent change from baseline in Numeric
Pain Rating Scale (NPRS) scores to Weeks 2-12. Safety and tolerability assessments included adverse events (AEs) and
pain during and
after treatment.
RESULTS: Patients (n = 239) treated with
NGX-4010 for 30 minutes demonstrated significantly (p = 0.0026) greater
pain relief compared with controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 2-12 was -27.0% versus -15.7%, respectively. Patients who received a 60-minute application of
NGX-4010 (n = 243) showed comparable
pain reductions (-27.5%) to patients treated for 30 minutes, but this was not statistically superior to controls (n = 115).
NGX-4010 was effective regardless of gender, baseline
pain score, duration of HIV-DSP, or use of concomitant
neuropathic pain medication, although
NGX-4010 efficacy was greater in patients not receiving concomitant
neuropathic pain medications.
NGX-4010 was well tolerated; the most common AEs were application-site
pain and
erythema, and most AEs were mild to moderate. The transient increase in
pain associated with
NGX-4010 treatment decreased the day
after treatment and returned to baseline by Day 2.
CONCLUSIONS: C107 = NCT00064623; C119 = NCT00321672.