P-021 - Ongoing Treatments with High Concentration Capsaicin Topical System Results in Progressive Pain Reduction for Painful Diabetic Neuropathy: A Retrospective Real-World Analysis

Abstract Title: Ongoing Treatments with High Concentration Capsaicin Topical System Results in Progressive Pain Reduction for Painful Diabetic Neuropathy: A Retrospective Real-World Analysis


Background: The capsaicin 8% topical system is approved by the FDA for the treatment of neuropathic pain associated with diabetic neuropathy of the feet (PDPN) and post-herpetic neuralgia¹. This analysis explored whether patients receiving ongoing treatment with capsaicin 8% topical system for PDPN reported a progressive response in pain reduction.

Purpose/Objectives:



The purpose of this study was to evaluate the progressive response in pain reduction among patients with painful diabetic peripheral neuropathy (PDPN) receiving repeated treatments with the capsaicin 8% topical system. Specifically, the study aimed to determine whether ongoing treatment with capsaicin 8% results in a sustained and cumulative reduction in pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), over multiple treatment sessions.







Methods: Eighteen patients who received at least 3 treatments with capsaicin 8% were initially selected for this analysis. Out of the eighteen patients, six were not included in the final data set due to missing quantitative post-treatment pain scores. Efficacy was measured using the Numeric Pain Rating Scale (NPRS) with values from 0-10, with 0 meaning “no pain” and 10 meaning “worst possible pain”. The pre-treatment pain intensity score (NPRS) was collected by the clinician, as part of routine practice, prior to administering capsaicin 8%, with the post-treatment pain intensity score (NPRS) measured during an evaluation preceding the next application of capsaicin 8% topical system.


Results: Most patients reported a response, defined by the treating clinician as a 50% or greater reduction in pain on average, with fifteen patients responding on the first treatment, one on the second treatment, and two not responding. Patients experienced a reduction in average pain intensity following each application with capsaicin 8%, with an additional progressive reduction in pre-treatment pain scores prior to the second and third applications (Figure 1).

Conclusions/Implications for future research and/or clinical care: Capsaicin 8% induces analgesia by directly and temporarily lysing aberrant nociceptive fibers responsible for transmitting signals of pain^2,3. Over time and as a consequence of diabetes, aberrant nociceptors may regrow resulting in the recurrence of pain associated with PDPN³. This study shows that with each successive treatment, pain levels were further reduced, which is consistent with previous findings showing more normal nerve fiber regrowth and progressive response in PDPN patients^3,4.

References:

1. QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc


2. Kennedy WR, Vanhove GF, Lu SP, Tobias J, Bley KR, Walk D, Wendelschafer-Crabb G, Simone DA, Selim MM. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain. 2010 Jun;11(6):579-87.


3. Anand P, Privitera R, Donatien P, Fadavi H, Tesfaye S, Bravis V, Misra VP. Reversing painful and non-painful diabetic neuropathy with the capsaicin 8% patch: Clinical evidence for pain relief and restoration of function via nerve fiber regeneration. Front Neurol. 2022 Oct 26;13:998904.


4. Freynhagen R, Argoff C, Eerdekens M, Engelen S, Perrot S. Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications. Pain Med. 2021 Oct 8;22(10):2324-2336.