Publication extender

Effect of capsaicin (8%) topical system on sensory function in patients with diabetic peripheral neuropathy: Analysis of the PACE study

Averitas Pharma

DOI: 10.26303/32w4-vp32

This page is intended for US healthcare professionals only and provides a summary of Katz NP, et al. Muscle & Nerve. 2026;73:1109–1117. It is a simplified representation created by Averitas Pharma, and should not be considered a replacement for the full article or its abstract. This publication was developed with support from Averitas Pharma. Please refer to the original publication for further details and disclosures. This publication contains data on sensory outcomes that extend beyond the FDA-approved labeling. Capsaicin 8% topical system is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy of the feet and postherpetic neuralgia. The safety and effectiveness of capsaicin 8% topical system for uses not described in the approved labeling have not been established. The data presented here should not be interpreted as support for uses outside the approved labeling. Read the Indication and Select Important Safety Information.

What is it about?

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.

Why is it important?

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:

  • Changes in sensory function are common in patients with PDPN
  • This post-hoc analysis evaluated sensory function following repeated treatment with HCCTS plus SOC versus SOC alone
  • Over time, more positive than negative sensory shifts were observed across sensory assessments with HCCTS plus SOC, and some patients with below-normal sensory function at baseline demonstrated normal sensory function at the end of the study
  • Improvements across several sensory function tests and patient-reported outcomes compared to SOC alone were also observed

--- 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

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Who is involved?

Indication and Select Important Safety Information

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.

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