Summary of "How Does QUTENZA® Work?"

  • Prevalence and Impact: About 20% of people with diabetes develop painful diabetic peripheral neuropathy (DPN), a chronic pain condition linked to nerve damage and altered neural signaling pathways.

  • Mechanism of Action: QUTENZA® utilizes capsaicin, a selective agonist for TRPV1 receptors, to increase activity at these receptors, leading to the desensitization of pain-transmitting fibers.

  • Delivery System: The product features patented matrix technology that allows for rapid and concentrated delivery of capsaicin, facilitating effective treatment by targeting TRPV1 expressing fibers directly through the skin. 

  • Treatment Schedule and Regeneration: Pain relief can be sustained with treatments every three months, as TRPV1 fibers may regenerate and reactivate, potentially leading to the return of pain.

  • Safety Information: Administration must be performed by healthcare professionals due to potential severe irritation and the need for protective measures. Common side effects include application site reactions and transient increases in blood pressure.

Did You Know

QUTENZA® uses capsaicin to trigger a reversible ablation of TRPV1 expressing fibers. This means that while it effectively reduces pain by desensitizing these fibers, they can regenerate over time, potentially leading to a return of pain, which allows for scheduled treatments every three months as needed.

Transcript

Approximately 20% of people living with diabetes will develop painful diabetic peripheral neuropathy (DPN), a progressive and potentially debilitating chronic neuropathic pain condition. Patients with DPN suffer from nerve damage that results in sensory changes, which can be painful as the disease progresses. Painful DPN is associated with alterations in neural signaling pathways, particularly those involving C and A-delta fibers, two types of nociceptive fibers responsible for transmitting sensations commonly associated with pain.

TRPV1 receptors located on C and A-delta fibers are normally activated in response to heat, controlling neuronal excitability and relaying pain signals from the periphery to the central nervous system. In chronic pain states, TRPV1 receptors are upregulated on neurons, resulting in increased neuronal excitability and pain perception. Cenza is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

The Cenza topical system is a localized, non-systemic, non-opioid treatment with no known drug-drug interactions that treats pain differently by directly targeting TRPV1-expressing nociceptive fibers responsible for the pain associated with DPN of the feet. Capsaicin, the main ingredient in Cenza, is a selective agonist for the TRPV1 receptor. Cenza increases TRPV1 receptor activity, leading to desensitization of the nociceptive fibers that are associated with transmitting painful sensations.

Uniquely, Cenza triggers a chemical cascade that results in a reversible ablation of the TRPV1-expressing fibers. The Cenza topical system combines a unique mechanism of action and patented matrix technology, which are essential for a fast and concentrated delivery of capsaicin. When applied to the skin, the matrix technology creates a force diffusion and rapidly releases a high concentration of capsaicin, which penetrates through the epidermal layers, resulting in desensitization and reversible ablation of the TRPV1-expressing fibers.

Clinical data show that Cenza provides significant and sustained relief of pain associated with DPN of the feet following the first treatment. The chemical ablation induced by Cenza is reversible over time. TRPV1-expressing fibers regenerate and reinnervate the epidermal layers, where some may become hyperactive again, resulting in the return of pain. Treatment with Cenza may occur every three months or as warranted by the return of pain, but not more frequently than every three months.

Due to its unique patented technology and targeted mechanism of action, ongoing treatments with Cenza can help patients living with DPN of the feet find relief from the debilitating pain associated with this often progressive disease.

Indication:

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

Important Safety Information:

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

Warnings and Precautions:

  • Severe Irritation: When 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 the face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch.

  • Handling Exposure: Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of Cenza. Do not reexpose affected individuals to Cenza if respiratory irritation worsens or does not resolve.

  • Accidental Skin Contact: If skin not intended to be treated comes into contact with Cenza, apply cleansing gel, then wipe off with dry gauze. Thoroughly clean all areas and items exposed to Cenza and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer Cenza 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 Cenza. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication.

  • Increase in Blood Pressure: Transient increases in blood pressure may occur with Cenza treatment. Monitor blood pressure during and following the 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 Cenza treatment.

  • Sensory Function: Reductions in sensory function, generally minor and temporary, have been reported following administration of Cenza. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of Cenza. If sensory loss occurs, treatment should be reconsidered.

Adverse Reactions:

The most common adverse reactions (≥5% and greater than the 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 Incorporated at 1-877-900-6479 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full prescribing information for more details.

Are You Suffering From Diabetic Feet In South Carolina?

If you're suffering from diabetic feet you owe it to yourself to speak with our experienced South Carolina podiatrists as soon as possible. Please feel free to contact us online or call our Myrtle Beach office directly at 843.449.3668 to schedule your appointment. We are proud to service patients in any of our local podiatry offices including Carolina Forest, Surfside Beach, Conway, Little River, and Myrtle Beach.