9 NOVEMBER 2024epidermal nerve fiber density (ENFD) after the application of high concentrations of capsaicin in human skin was shown by staining skin biopsies with a pan-axonal marker, PGP 9.5.CLINICAL EVIDENCE IN PDPN:The efficacy of this therapy was established in the study STEP, which was a 12-week, double-blind, randomized, placebo-controlled, multicenter study. Both treatments were applied as a single, 30-minute application. The percent change in average pain from baseline to Week 12 was higher in the 8% capsaicingroup -30% (±3%) compared to the placebo group -22% (±3%). More patients achieved a 30% reduction in pain from baseline: 40.9% responders with 8% capsaicinvs 31.7% responders with placebo at Weeks 2­12 (P=0.050). In STEP, the 8% capsaicin patch was shown to provide sustained pain relief and a faster time to treatment response vs placebo in adult patients after a single application.Another study, the PACE study assessed the long-term safety and efficacy of repeated QUTENZA treatments plus SOC vs SOC alone over 52 weeks in patients with PDPN. The PACE study is a phase 3 randomized, controlled open label. During this period, QUTENZA repeat treatments plus SOC in patients with PDPN was well tolerated; patients had no functional neurologic decline and there were no other safety concerns. Also, although it was not the primary outcome of the study, efficacy data for the PACE study demonstrated that there was a greater proportion of patients with PDPN relief in the QUTENZA group compared with SOC alone, further sustained with long-term treatments.CLINICAL SAFETYSuch treatment is well tolerated. The most common adverse reaction (5% and greater than control) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus. Pretreatment with topical analgesic medications is recommended to preempt application site discomfort. Local cooling methods, including cool packs and/or appropriate analgesic medication, can be used to treat acute pain during and following the application procedure. In the STEP and PACE study the majority of application site reactions were transient and self-limited. A majority of treated patients in clinical trials (performed by Averitas Pharma) that had any adverse reactions reported a maximum intensity of "mild" or "moderate".
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