My practice is now offering QUTENZA® (capsaicin) 8% for the treatment of painful diabetic peripheral neuropathy (DPN) of the feet.1 We would be happy to support you in the management of this chronic condition in your patients to determine if QUTENZA is an appropriate treatment option.

QUTENZA is indicated in adult patients for the treatment of neuropathic pain associated with DPN of the feet or postherpetic neuralgia (PHN). QUTENZA is a nonopioid, non-systemic topical treatment that can be used alone or when oral treatments are not enough.1 QUTENZA is administered just 4 times each year during a 30-minute in-office procedure.1

QUTENZA offers a different way to treat patients with unresolved painful DPN of the feet1,2-6:

  • TREATS PAIN DIFFERENTLY: First and only noninvasive, in-office treatment that targets the root of neuropathic pain.1,7-9
  • SUSTAINED RELIEF MEASURED IN MONTHS, NOT DAYS*: In a clinical study of adult patients with painful DPN, QUTENZA demonstrated statistically and clinically significant pain relief for up to 3 months, as measured by reduction in daily pain scores, with a 36% relative difference (8% absolute difference) vs placebo.1,10  
  • ESTABLISHED SAFETY PROFILE: Topical treatment with a low risk of systemic side effects and no known drug-drug interactions that can be used alone or in combination with standard of care (SoC).1
  • IN THE PACE OPEN-LABEL SAFETY TRIAL†: 63% of patients preferred QUTENZA to their previous therapy, and 73% wanted to continue with QUTENZA treatments vs 31% and 52% for SoC alone, respectively.1,10-12

*In a Phase 3 clinical study, the percent change in average pain from baseline to Week 12 was -22% (±3%) for placebo and -30% (±3%) for QUTENZA. Approximately half (47.2%) of the patients in the study were taking concomitant medications, including anticonvulsants, non-selective serotonin reuptake inhibitor (SSRI) antidepressants, or opioids, at study entry and were required to keep dosing stable throughout the duration of the study.

†PACE was a 52-week, open-label, randomized, controlled safety study of QUTENZA (N=468). 156 patients were randomized to receive repeated 30-minute treatments of QUTENZA + SoC. Self-Assessment of Treatment questionnaire was not validated and could represent chance findings.

If patients are adjusting their daily life around the unresolved painful DPN of the feet, QUTENZA could be the answer.1,10

INDICATION
QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet.

IMPORTANT SAFETY INFORMATION

Do not dispense QUTENZA to patients for self-administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label.

Warnings and Precautions

  • Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re-expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well-ventilated area, and remove gently and slowly, rolling the adhesive side inward.
  • Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling and/or appropriate analgesic medication.
  • Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment-related pain. Patients with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment.
  • Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. Assess for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered.
  • Severe Application Site Burns: Full-thickness (third-degree) and deep partial-thickness (second-degree) burns have been reported following administration of QUTENZA. Cases of full-thickness (third-degree) burns, requiring hospitalization and skin grafting have been reported in patients who received QUTENZA for an unapproved indication and/or frequency of dosing at an application site where there had been prior skin trauma. Ensure that dosage and administration recommendations are followed.

Adverse Reactions

The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1-877-900-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Please reach out to us for more information about QUTENZA.

Sincerely,

Dr. Eric Harmelin

References:

1. QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc. 2. Schreiber AK, Nones CF, Reis RC, et al. Diabetic neuropathic pain: physiopathology and treatment. World J Diabetes. 2015;6(3):432-444. 3. Biotechnology Information. PubChem Patent Summary for US-8821920-B2: Therapeutic patch for transdermal delivery of capsaicin. PubChem website. https://pubchem. ncbi.nlm.nih.gov/patent/US-8821920-B2. Accessed March 17, 2023. 4. Wohlrab J, Neubert RH, Heskamp ML, et al. Cutaneous drug delivery of capsaicin after in vitro administration of the 8% capsaicin dermal patch system. Skin Pharmacol Physiol. 2015;28(2):65-74. 5. Peppin JF, Pappagallo M. Capsaicinoids in the treatment of neuropathic pain: a review. Ther Adv Neurol Disord. 2014;7(1):22- 32. 6. Yang H, Sloan G, Ye Y, et al. New perspective in diabetic neuropathy: from the periphery to the brain, a call for early detection, and precision medicine. Front Endocrinol (Lausanne). 2020;10:929. 7. Nolano M, Simone DA, Wendelschafer-Crabb G, et al. Topical capsaicin in humans: parallel loss of epidermal nerve fibers and pain sensation. Pain. 1999;81(1-2):135-145. 8. Malmberg AB, Mizisin AP, Calcutt NA, et al. Reduced heat sensitivity and epidermal nerve fiber immunostaining following single applications of a high-concentration capsaicin patch. Pain. 2004;111(3):360- 367. 9. Kennedy WR, Vanhove GF, Lu SP, et al. 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;11(6):579-587. 10. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18(1):42-53. 11. Vinik AI, Perrot S, Vinik EJ, et al. Repeat treatment with capsaicin 8% patch (179mg capsaicin cutaneous patch): effects on pain, quality of life, and patient satisfaction in painful diabetic peripheral neuropathy: an open-label, randomized controlled clinical trial. Curr Med Res Opin. 2019;2(12):388-401. 12. Vinik AI, Perrot S, Vinik EJ, et al. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/ s12883-016-0752-7. PMID: 27919222; PMCID: PMC5139122. https://pubmed.ncbi.nlm.nih.gov/27919222/.

 

 

Eric Harmelin, DPM
Eric Harmelin, DPM
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Experienced Amputation Prevention Specialist and Podiatrist in Annapolis and Stevensville, Maryland.