Qutenza (capsaicin) / Astellas, Grunenthal, LTS Lohmann Therapy Systems, Apotex - LARVOL DELTA

A DECISION TREE ESTIMATING TOTAL COST OF CARE USING EXPOSURE-ADJUSTED DISCONTINUATION: CAPSAICIN 8% VERSUS ORAL TREATMENTS FOR PAINFUL DIABETIC NEUROPATHY IN THE UNITED STATES (ISPOR 2026) - "OBJECTIVES: To estimate 12-month total cost of care due to discontinuation for topical capsaicin 8% (HCCTS) versus oral PDPN treatments from a US payer perspective as existing PDPN economic models inadequately capture the cost of therapy withdrawal and related medical costs. A decision tree model simulated 1,000 adults initiating PDPN treatment with HCCTS or oral agents (duloxetine, pregabalin, gabapentin, amitriptyline, venlafaxine, topiramate); structurally the tree aligned to capsaicin's three-month (3M) retreatment intervals. Exposure-adjusted cost modeling using trial reported withdrawals estimated HCCTS on treatment time was up to 3x greater vs orals. HCCTS persistence meant fewer medical costs, offsetting drug acquisition costs to yield annual total cost savings of $0.7M-$25.7M vs PDPN oral alternatives for a cohort of 1,000 patients."

Cost of care • HEOR • Diabetic Neuropathy • Pain

Cold Feet, Warm Patch: Capsaicin Patch Therapy for Neuropathic Pain in Non-Freezing Cold Injury (PainConnect 2026) - No abstract available

Neuralgia • Pain

Cooling the burn: EMLA alone vs. paravertebral block plus EMLA for improving tolerability of 8% capsaicin patch application in thoracic postherpetic neuralgia-a retrospective cohort study. (PubMed, Front Aging Neurosci) - "TPVB combined with EMLA yielded profound improvements in procedural tolerability, early pain control, sleep quality, and patient acceptability during 8% capsaicin patch therapy for thoracic PHN, while markedly reducing opioid rescue needs. These findings support TPVB-assisted capsaicin therapy as a promising multimodal strategy deserving evaluation in prospective controlled trials."

Journal • Retrospective data • Neuralgia • Pain

Q-HEAL-001: A randomized, double-blind, placebo-controlled study to assess the effects of high concentration capsaicin patch (Qutenza) on neuropathic symptoms, nerve fibers, and microcirculation in painful diabetic peripheral neuropathy (clinicaltrialsregister.eu) - P1/2 | N=40 | Not yet recruiting | Sponsor: Deutsche Diabetes Forschungsgesellschaft e.V.

New P1/2 trial • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Clinical prediction in treatment with 8% capsaicin patch for post-traumatic neuropathic pain: a critical perspective based on accumulated evidence. (PubMed, Rev Esp Anestesiol Reanim (Engl Ed)) - No abstract available

Journal • Neuralgia • Pain

Progressive Improvements with Repeated High-Concentration Capsaicin Patch: Real-World Data from the Retrospective CASPAR German Pain e-Registry Study in Postherpetic Neuralgia. (PubMed, Dermatol Ther (Heidelb)) - "HCCP is an effective and well-tolerated topical treatment for patients with PHN, including older adults. After one treatment, improvements were noted in API, QoL, sleep, and mood outcomes, alongside decreased concomitant pain medication use, with progressive improvements following additional treatments. A Graphical Abstract is available for this article."

Journal • Real-world evidence • Retrospective data • Neuralgia • Pain

Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Pain • Peripheral Neuropathic Pain

Real-world 12-month outcomes of repeated high-concentration capsaicin patch in chemotherapy-induced peripheral neuropathy: results from the CASPAR study. (PubMed, Front Oncol) - "Adverse events were mostly mild, transient, and limited to the application site. This real-world analysis indicates that repeated HCCP treatment is associated with progressive improvements in pain intensity, QoL, and functional outcomes in patients with CIPN, while maintaining good long-term tolerability."

Journal • Real-world evidence • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Understanding the Use and Impact of Capsaicin 8% Patches: A Patient-Centered Study on Efficacy, Adverse Effects, and Repeat Usage (ASHP 2025) - No abstract available

Adverse events • Clinical

High-concentration (8%) capsaicin patch for chronic postoperative neuropathic pain: A systematic review of randomised controlled trials. (PubMed, Br J Pain) - "High-quality studies are needed to expand the existing evidence base. Based on our findings, we propose several recommendations to guide future research in this area."

Journal • Neuralgia • Pain

Cannabidiol induces antiallodinic and antihiperalgesic effects via D2-NFKB dopamine receptor in hemiparkinsonian male rats (Neuroscience 2025) - "Most patients with Parkinson's disease have neuropathic pain and do not receive adequate treatment or do not respond to treatment, even though there are various first-line treatments, such as tricyclic antidepressants, gabapentin, pregabalin, duloxetine and fluoxetine. There are alternative treatments such as lidocaine or capsaicin patches, opioids, and cannabis...On the other hand, we find a decrease in NFKB immunoreactivity and cytokines production. These results show that CBD has analgesic activity and exerts it effect by D2DR via NFKB in 6-OHDA-lesion male rats."

Preclinical • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Neuralgia • Parkinson's Disease • Psychiatry • Schizophrenia • DRD2

Utility Values From Pooled Analysis of High Concentration (179 mg) Capsaicin Patch (HCCP) Studies In Peripheral Neuropathic Pain (PNP) (ISPOR-EU 2025) - "This pooled analysis of clinical trials provides robust utility estimates that capture the quality-of-life impact of different pain severities in PNP. The clear separation between pain-defined utility states highlights the substantial impact of even moderate pain on patient quality of life and supports the relevance of pain-defined health states in health economic evaluations."

Retrospective data • Neuralgia • Pain • Peripheral Neuropathic Pain

Real-world evidence on repeated high-concentration (179 mg) capsaicin patch (HCCP) treatment for chemotherapy-induced peripheral neuropathy (CIPN) — focusing on pain relief, quality of life (QoL) and reduced systemic analgesic use (CASPAR study) (DGHO 2025) - "The results indicate that repeated HCCP treatments may improve pain, sleep, and QoL in patients with CIPN, while reducing the need for systemic medications. Tolerability was favorable, with mostly mild local ADRs that became less frequent with repeated use."

Clinical • HEOR • Real-world • Real-world evidence • Dermatology • Immunology • Pain • Peripheral Neuropathic Pain • EREG

Comprehensive insights into diabetic peripheral neuropathy: pathophysiology and therapeutic approaches. (PubMed, J Diabetes Metab Disord) - "The United States Food and Drug Administration has approved pharmacological treatments for painful diabetic peripheral neuropathy: pregabalin, duloxetine, gabapentin, extended-release tapentadol, tramadol, and the capsaicin 8% patch. Non-Food and Drug Administration-approved therapies, such as amitriptyline and the 5% lidocaine patch, are also widely used...A multifaceted approach incorporating pharmacological and non-pharmacological therapies is essential for optimizing patient outcomes in diabetic peripheral neuropathy. Targeting underlying pathophysiological mechanisms while providing symptomatic relief can enhance treatment efficacy and improve the quality of life for individuals with diabetic peripheral neuropathy."

Journal • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

High dose topical capsaicin in the treatment of meralgia paresthetica: a case report. (PubMed, Pain Manag) - "She had previously tried lidocaine 5% patch, capsaicin 0.1% patch, gabapentin, and oxycodone, with minimal relief. This off-label use of capsaicin 8% patch showed promise for pain management for MP. However, prospective studies are needed to determine the long-term efficacy, safety, and optimal dosing.High-Dose Capsaicin Patch Relieved Thigh Nerve Pain in a Complex Patient - Plain Language Summary."

Journal • Fibrosis • Hematological Disorders • Immunology • Infectious Disease • Neuralgia • Pain • Thrombocytopenia

Long-Term Efficacy and Safety of Treatments for Peripheral Neuropathic Pain: A Systematic Review (NeuPSIG 2025) - "For 4 treatments ≥5 studies with duration ≥ 6 months had been published (all 4 identified in the original search and 1 via the addendum search).The highest number of studies was recorded for high concentration (179mg) capsaicin patch (n=9; 6 with follow up >6 months) followed by duloxetine (n=7; 4 with follow up >6 months), gabapentin (n=6; 1 with follow up >6 months) and pregabalin (n=5; 3 with follow up >6 months). Although PNP is a chronic disorder often requiring long-term treatment, only 4 of the first- and second-line therapies recommended by NeuPSIG, have ≥5 published studies evaluating their long-term efficacy/effectiveness in PNP patients. A substantial evidence gap remains for all other treatments recommended for PNP in the NeuPSIG guidelines, underscoring the need for long-term research, and long-term data (with evaluation of ≥ 6 months) for future guidelines.Table 1: Original in and exclusion criteria"

Clinical • Review • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

QUTENZA (8% Capsaicin Plaster) Efficacy and Tolerability, an observational clinical study (NeuPSIG 2025) - "Our data will reinforce and add objectivity for the consideration of capsaicin plaster in treatment of localised neuropathic pain where conventional anti neuropathic have failed or have not been tolerated by patients. The initial results suggest increasing trend towards better patient satisfaction, reduction of sedative pain medications and improved quality of life for selected patient cohorts. We look forward to presenting our data in greater detail at the conference."

Clinical • CNS Disorders • Neuralgia • TRPV1

Effect of high concentration capsaicin patch (HCCP) treatment on neuropathic pain symptoms across etiologies: data from clinical practice (CASPAR) (NeuPSIG 2025) - "In this cohort of patients with PNP and largely comparable baseline characteristics, distinct symptom patterns were observed accross etiologies. Treatment with HCCP was associated with a reduction in PDQ7 item scores across etiologies. However, the extent of improvement varied among individual symptoms."

Clinical • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • EREG

Is there benefit from treatment with a topical TRPV-1 agonist in Complex Regional Pain Syndrome (CRPS): observational cohort study (CASPAR) (NeuPSIG 2025) - "This study evaluates the effect of repeated treatment with high concentration (179 mg) capsaicin patch (HCCP) on pain intensity, sleep quality, quality of life (QoL) and daily functioning and tolerabilty in patients with CRPS under real-world clinical conditions. This retrospective cohort study is part of a broader investigation analyzing anonymized routine care data from the German Pain eRegistry... Repeated HCCP treatment in CRPS patients led to important improvements in pain intensity, sleep, QoL, and suicidal ideation in this study. Application site reactions, which were primarily mild to moderate were noted in association with the application process."

Observational data • CNS Disorders • Mood Disorders • Musculoskeletal Pain • Pain • Psychiatry • Suicidal Ideation • EREG

Topical treatment of chemotherapy-induced peripheral neuropathy (CIPN) with high concentration capsaicin patch (HCCP): results of an observational cohort study (CASPAR) (NeuPSIG 2025) - "Repeated HCCP treatment was associated with progressive reductions in pain intensity and neuropathic symptoms in patients with CIPN. A significant proportion of non-responders after the first treatment converted to responders following additional treatments. Improvements in all individual painDETECT® symptoms were observed, with the most notable improvement in allodynia."

Observational data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • EREG

Osteopathic supportive care in oncology on neuropathic pain after breast cancer: ALGOS RCT pilot study (NeuPSIG 2025) - "TAU is characterized by capsaicin patch application delivered by the medical algological team... Further studies with more substantial size samples are needed to support osteopathy as a relevant supportive care option for patients with post-mastectomy neuropathic pain syndrome."

Clinical • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain

Evaluation of the treatment effect of capsaicin (179mg) patch on Chronic Regional Pain syndrome (NeuPSIG 2025) - "The findings suggest that Capsaicin 179mg transdermal is an effective approach to managing localized PNP secondary to CRPS, contributing to substantial improvements in quality of life and reductions in pain interference and intensity. The treatment's ability to provide sustained relief with minimal systemic side effects makes it a valuable alternative to conventional pharmacological approaches. Findings support the use of Capsaicin 179mg as a viable option for neuropathic pain in those diagnosed with CRPS and highlights the need for further research to confirm these results in larger and more diverse patient populations."

CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain • Sleep Disorder

Health Care Professionals’ Perspectives of Inadequately Managed Painful Diabetic Peripheral Neuropathy: A Qualitative Analysis (PAINWeek 2025) - "Five products have been approved by the US Food and Drug Administration (FDA) for the management of pain associated with DPN: duloxetine, pregabalin, tapentadol, capsaicin 8% patch, and spinal cord stimulation devices...The most frequently prescribed first-line therapies included gabapentin (n=16), pregabalin (n=7), topical creams (n=7), and duloxetine (n=6)... Twenty HCPs participated in the study, with an equal distribution between generalists (family medicine or internal medicine; n=10) and specialists (neurology, n=5; pain medicine, n=5). The sample was mostly male (n=13, 65%) and White (n=11, 55%). On average, participants had 24.3 years of experience managing painful DPN and reported treating between 2-50 patients with pain associated with DPN per week."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Epilepsy • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry • Sleep Disorder

Cost-Effectiveness of a High-Concentration (179 mg) Capsaicin Patch for the Treatment of Patients with Peripheral Neuropathic Pain in Scotland. (PubMed, Pain Ther) - "HCCP is a cost-effective add-on therapy for the treatment of adults with PNP in Scotland, with consistent findings across diabetic and non-diabetic populations. These results support the benefits of integrating HCCP in healthcare systems and clinical practice, both in terms of patient outcomes and economic benefits for the system."

HEOR • Journal • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery (clinicaltrials.gov) - P3 | N=409 | Completed | Sponsor: Averitas Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Neuralgia • Pain