Painful diabetic peripheral neuropathy of the feet: Integrating prescription-strength capsaicin into office procedures
Journal article
Published on September 26, 2023

Painful diabetic peripheral neuropathy of the feet: Integrating prescription-strength capsaicin into office procedures

Contributors:

Landrum O, Marcondes L, Egharevba T et al.

Name of journal:

Pain Management

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DOI:

10.2217/pmt-2023-0028

Topics:

DPN Lit review Case report Peripheral neuropathic pain Capsaicin 8% topical system
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This page provides a summary of Landrum O et al. Pain Manag. 2023;13(10):613–26. It is a simplified representation of the key points that was created by Averitas Pharma, and should not be considered a replacement for the full article or its abstract. Please refer to the original publication for further details and disclosures.

Summary

This article reviews existing literature and provides practical application instructions for the integration of capsaicin 8% topical system into clinic or office procedures for the treatment of painful diabetic peripheral neuropathy of the feet1

Learn more about how capsaicin 8% topical system can be integrated in medical office procedures for the treatment of painful diabetic peripheral neuropathy of the feet
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Learn more about how capsaicin 8% topical system can be integrated in medical office procedures for the treatment of painful diabetic peripheral neuropathy of the feet

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Background

Diabetic peripheral neuropathy is a common complication associated with diabetes, resulting from dysfunction of peripheral nerve fibers.1,2 Patients with diabetic peripheral neuropathy often experience neuropathic pain (painful diabetic peripheral neuropathy), which typically starts in the feet and gradually moves proximally.1

Distal-to-proximal progression of diabetic peripheral neuropathy<sup>1</sup>
Distal-to-proximal progression of diabetic peripheral neuropathy1

Aim

This article provides an overview of the role of capsaicin 8% topical system in the treatment landscape for painful diabetic peripheral neuropathy of the feet, along with practical information for healthcare professionals on its use in office settings.1

Application of capsaicin 8% topical system on the foot of a patient with painful diabetic peripheral neuropathy of the feet
Application of capsaicin 8% topical system on the foot of a patient with painful diabetic peripheral neuropathy of the feet

Treatment options for painful diabetic peripheral neuropathy

The primary treatment objective for painful diabetic peripheral neuropathy is to alleviate pain while enhancing patient function and quality of life.1 Safety, tolerability, and drug-drug interactions (DDIs) should be considered carefully, given the high pill burden often faced by diabetic individuals.1

First-line and recommended pharmacological treatments for painful diabetic peripheral neuropathy, based on the 2022 American Association of Clinical Endocrinology guidelines3 and the American Diabetes Association clinical compendium,4 include1:

Subsequent-line therapy includes switching to a different first-line therapy or combining different pharmacological agents or pharmacological plus non-pharmacological options.1

Capsaicin 8% topical system for the treatment of painful diabetic peripheral neuropathy of the feet

Mechanism of action

Capsaicin 8% topical system is a neurolytic agent designed to specifically target neuropathic pain by acting locally on pain sensing (nociceptive) nerve fibers in the outermost layers of the skin.1 The matrix technology in the topical system leverages the selective binding of capsaicin on transient receptor potential vanilloid 1 (TRPV1) channels that are overexpressed on nociceptive fibers and play a key role in pain sensation.1 The high concentration capsaicin chemically lyses the targeted nociceptive fibers reducing their responsiveness to painful stimuli and providing pain relief.1

Capsaicin 8% topical system acts locally on nociceptive nerve fibers in the outermost layers of the skin<sup>1</sup>
Capsaicin 8% topical system acts locally on nociceptive nerve fibers in the outermost layers of the skin1

Efficacy and tolerability in clinical trials

Efficacy

The STEP study showed that a single 30-min treatment with capsaicin 8% topical system provided sustained pain relief for up to 3 months in patients with painful diabetic peripheral neuropathy of the feet.1,5

Safety

Due to the low systemic absorption, capsaicin 8% topical system does not present any known risk of DDIs, has no contraindications, and does not require dosage adjustments in special populations.1 It is well tolerated and has no reported systemic adverse drug reactions (ADRs).1,5,6 Application-site reactions are the most commonly reported ADRs.1,5,6 These results are supported by two phase 3 randomized controlled trials in patients with painful diabetic peripheral neuropathy, one evaluating the efficacy and safety of a single application of capsaicin 8% topical system (STEP study)1,5 and one exploring its long-term safety upon repeated treatment (PACE study).1,6

Incorporation into office procedures

The capsaicin 8% topical system must be applied by healthcare professionals in an office setting and cannot be self-administered by patients.1 Up to four topical systems can be used per treatment, and treatment may be repeated every 3 months or as warranted by the return of pain, but not more frequently than every 3 months.1

Instructions for applying capsaicin 8% topical system must be followed to prevent unintentional exposure to capsaicin, minimize application-site pain, and ensure patients are well-informed about the treatment.1

Read here to learn more about the instructions on how to apply capsaicin 8% topical system.

Conclusions

Capsaicin 8% topical system can provide clinically relevant benefits in patients with painful diabetic peripheral neuropathy of the feet.1 It has no known systemic ADRs, contraindications, or DDIs.1 Application-site reactions are the most commonly reported ADRs.1

The capsaicin 8% topical system can only be administered by healthcare professionals in a clinic or office setting.1 As no self-management is needed between visits, patients may tend to adhere to the treatment plan.1

Limitations

No specific limitations were described in the article; however, the authors noted that further research and real-world evidence on capsaicin 8% topical system for painful diabetic peripheral neuropathy of the feet is needed to identify factors associated with treatment response and guide best practices.1

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Footnotes

aNot all oral agents recommended by the 2022 guidelines from the American Association of Clinical Endocrinology3 and the American Diabetes Association clinical compendium4 are FDA-approved for painful diabetic peripheral neuropathy (information updated in February 2025).

ADR, adverse drug reaction; DDI, drug-drug interaction; FDA, United States Food and Drug Administration; TRPV1, transient receptor potential vanilloid 1; USA, United States of America.

QZA-01-25-0009 | March 2025