Averitas Pharma
This post-hoc analysis of the PACE study evaluated changes in sensory function in patients with painful diabetic peripheral neuropathy (PDPN), particularly those with baseline sensory deficits, following repeated 30-minute treatment with capsaicin 8% topical system (here referred to as high-concentration capsaicin topical system, HCCTS) plus standard of care (SOC), versus SOC alone. Sensory function was assessed using the Brief Sensory Pain Examination (BSPE), and patient-reported outcomes related to nerve fiber function and its impact on daily life were assessed using the Norfolk Quality of Life–Diabetic Neuropathy questionnaire.
PACE was a 52-week, Phase 3, open-label, randomized controlled study in 468 patients with PDPN of the feet, designed to evaluate the safety of repeated treatment with HCCTS. HCCTS is approved in the US for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. DPN is a complication of diabetes that can cause nerve pain and sensory dysfunction in the feet.
Limitations: This was a post-hoc analysis of the PACE study, which was not designed or powered to detect statistically significant differences in sensory function between treatment groups. Subgroup analyses included relatively small numbers of patients with below-normal sensory function at baseline. The BSPE includes commonly used bedside neurological tests but has not been formally validated to detect clinically meaningful changes in sensory function. The open-label, non-placebo-controlled study design may have introduced bias in interpretation of results. Attrition over time and changes in mobility, medication use, and metabolic control post treatment may have influenced observed sensory outcomes.
Patients with PDPN may experience changes in sensation in their feet, in addition to nerve pain. Understanding how repeated treatment may affect sensory function over time is an important clinical consideration in this population.
In this post-hoc analysis of the PACE study, repeated treatment with HCCTS plus SOC was associated with more positive than negative changes in sensory function across multiple assessments, and some patients with below-normal sensory function at baseline tested normal by the end of the study. In comparison with SOC alone, improvements in several sensory function assessments and patient-reported outcomes were observed.
Further research is needed to confirm these findings and better understand their clinical significance.
Key takeaways:
--- Abbreviations and references: BSPE, Brief Sensory Pain Examination; DPN, diabetic peripheral neuropathy; HCCTS, high-concentration capsaicin topical system; PDPN, painful diabetic peripheral neuropathy; SOC, standard of care.
Katz NP et al. Muscle & Nerve. 2026;73:1109–1117. Averitas Pharma provided financial and medical editorial support for the development of Katz NP, et al. Muscle & Nerve. 2026.
QZA-06-26-0005 | July 2026
Learn more about PACE post-hoc findings on sensory function with repeated high-concentration topical capsaicin treatment plus SOC in patients with PDPN
Explore sensory function outcomes evaluated in the PACE post-hoc analysis through interactive data visualizations and educational content.
Information updated in June 2026.
INDICATION
In the USA, capsaicin 8% topical system is indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
