Understanding Qutenza®: A Breakthrough Treatment for Painful Diabetic Peripheral Neuropathy (DPN)

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, in particular, 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, which results 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 forced 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 shows 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 Ksin 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 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, whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin to the healthcare professional and patients. Do not use near the 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. 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 re-expose affected individuals to Cenza if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with Cenza, apply cleansing gel and 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 (for example, 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 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 (greater than or equal to 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 1-877-964-7979 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full prescribing information.