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Morristown, N.J.– 4 May 2022

SPEAK FOR YOUR FEET

To Recognize Peripheral Neuropathy Awareness Week, Averitas Pharma Kicks Off Contest Calling on Patients to Describe Symptoms of Diabetic Nerve Pain and Improve Healthcare Professional-Patient Communication

  • Diabetic Nerve Pain often affects the feet, significantly impacts quality of life, and can be challenging to diagnose
  • Potentially devastating consequences underscore the importance of early detection
  • Winning memory aid (mnemonic) will help patients identify symptoms and foster communications with healthcare providers

Morristown, N.J.– 4 May 2022 — Today, Averitas Pharma, the U.S. subsidiary of Grünenthal, launched the Speak For Your Feet contest calling on patients with diabetic nerve pain, caregivers and healthcare professionals (HCPs) to create a mnemonic acronym describing and defining symptoms. The goal of this unique educational program is to increase awareness of the potential symptoms of diabetic nerve pain and to create a common language between patients and HCPs in discussing symptoms. This will help drive more productive conversations about identifying causes and potential solutions.

To celebrate their creativity, the winning entrant will receive a $1000 VISA gift card or two passes to Averitas Pharma’s collaborative partner American Chronic Pain Association (ACPA)’s 2023 Pain Freedom Conference in Colorado, with up to $1,500 for associated travel and lodging expenses. In addition, three runners up will receive a $100 VISA gift card.

Averitas invites the community to submit a 4-10 letter mnemonic acronym for diabetic nerve pain, where each letter can represent key symptoms associated with the condition, reminders about related aspects of health, and/or a call to action for patients to speak to an HCP. Submissions should focus on symptoms of diabetic nerve pain of the feet as the patient experiences and describes them, such as tingling, numbness, and burning sensations, as well as important next steps, such as controlling glucose levels, patient self-advocacy, and discussing their condition with an HCP.

A mnemonic device is a memory aid or tool that helps people remember a concept or phrase by using a pattern of letters, ideas or associations - such as F.A.S.T.E.R. that is meant to help remember and identify the symptoms of a stroke.4

“We launched this unique contest in the community to better understand how patients describe diabetic nerve pain of their feet in their own terms,” said Dr. Lizandra Marcondes, Head Medical Affairs Averitas Pharma. “By redefining the symptoms using their own words, our goal is to help diabetic peripheral neuropathy patients and their health care providers start using common language to talk about their symptoms, fostering more productive conversations around diagnosis, disease management and potential solutions.”

“Diabetic nerve pain of the feet is called ‘the silent pain’ because it often starts with more subtle and less painful symptoms, which creates difficulties in properly diagnosing it,” said Kathy Sapp, CEO of ACPA. “This ‘silence’ coupled with its potentially devastating consequences if left unaddressed, highlights the importance of patients and their loved ones recognizing the symptoms of diabetic nerve pain, and seeking care for it, as early as possible.”

The winning entry will be used in educational resources and other materials to help people who have diabetes, or may have diabetes, remember, better identify and seek care for symptoms of diabetic nerve pain of the feet.

For Official Rules and entry details, please visit www.nervepainandme.com/contest. Entries must be received by October 1st, 2022. The winning entry and three runners up will be announced on or around November 1st, 2022. Must be 18 years of age or older to participate. Promotion is void where prohibited or restricted by law. No purchase is necessary to enter.

About Diabetic Nerve Pain
Neuropathic pain associated with diabetes, is a progressive and debilitating complication of diabetes that affects over 5.7 million Americans,1 with numbers expected to double by 2030.2 Diabetic nerve pain most often affects the extremities such as the feet and hands, but instead of actual pain, patients may first experience numbness and tingling. As the condition intensifies, symptoms can include severe pain, sensitivity to cold temperatures, and burning, shooting or stabbing sensations.3 Diabetic nerve pain can be an extremely challenging condition to diagnose, treat and manage effectively, and the excruciating pain patients may experience has a significant impact on their quality of life.

About Averitas Pharma, Inc.
Averitas Pharma is a specialty pharmaceutical company dedicated to delivering innovative, effective, non-opioid pain management options to patients in the U.S. The company was formed in 2018, as a subsidiary of GRT U.S. Holding, Inc., and member of the Grünenthal Group. For more information, visit www.averitaspharma.com.

About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better - and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

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IMPORTANT U.S. SAFETY INFORMATION


INDICATION

QUTENZA® (capsaicin) 8% patch 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.

IMPORTANT SAFETY INFORMATION

Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle QUTENZA.

Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. When administering QUTENZA, it is important to follow these procedures:

  • Administer QUTENZA in a well-ventilated treatment area.
  • Wear only nitrile gloves when handling QUTENZA or any item that makes contact with QUTENZA, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection.
  • Use of a face mask and protective glasses is advisable for healthcare providers.
  • Keep QUTENZA in the sealed pouch until immediately before use.
  • Use QUTENZA only on dry, intact (unbroken) skin.
  • In patients treated for neuropathic pain associated with diabetic peripheral neuropathy, a careful examination of the feet should be undertaken prior to each application of QUTENZA to detect skin lesions related to underlying neuropathy or vascular insufficiency.
  • During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.
  • Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward.
  • Immediately after use, clean all areas that had contact with QUTENZA and properly dispose of QUTENZA, associated packaging, Cleansing Gel, gloves, and other treatment materials in accordance with local biomedical waste procedures.
  • If QUTENZA is cut, ensure unused pieces are properly disposed of.

Contraindications

None

Warnings and Precautions

  • Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin.
  • Do not apply QUTENZA to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching QUTENZA or items exposed to capsaicin and then touching the eyes and mucous membranes. Wear nitrile gloves when administering QUTENZA and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of QUTENZA and flush eyes and mucous membranes with cool water.
  • Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. Provide supportive medical care if shortness of breath develops.
  • If skin not intended to be treated is exposed to QUTENZA, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.
  • Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling (such as a cold pack) and/or appropriate analgesic medication.
  • Transient increases in blood pressure may occur during and shortly after the QUTENZA treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate 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.
  • Reductions in sensory function have been reported following administration of QUTENZA. Decreases in sensory function are generally minor and temporary. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.

Adverse Reactions

In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.

Adverse Event Reporting

Physicians, other healthcare providers, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can:

  • In the U.S., visit www.fda.gov/medwatch or call 1-800-FDA-1088; or
  • For QUTENZA, you may also call 1-877-900-6479 and select option 1, or press zero on your keypad to talk to an operator to direct your call.

Please see full Prescribing Information at https://www.qutenza.com/pdfs/Qutenza_Prescribing_Information.pdf.

References
  1. LTP 2020-2030: ADDRESSABLE POPULATIONS BY CONDITION (PDPN, PSNP, PHN, CINP). Company data on file. April 30, 2020.
  2. Gore, M., Brandenburg, N. A., Dukes, E., Hoffman, D. L., Tai, K.-S., & Stacey, B. (2005). Pain Severity in Diabetic Peripheral Neuropathy is Associated with Patient Functioning, Symptom Levels of Anxiety and Depression, and Sleep. Journal of Pain and Symptom Management, 30(4), 374-385. doi:10.1016/j.jpainsymman.2005.04.009 https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html.
  3. Vinik, Aaron I., 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; Journal of Current Medical Research and Opinion 2.12 (2019): 388-401.
  4. https://www.beaumont.org/health-wellness/blogs/stroke-symptoms-from-fast-to-faster. Accessed April 13, 2022.
  5. CDC Division of Diabetes Translation, National Diabetes Statistics Report, 2020. https://www.cdc.gov/diabetes/library/features/diabetesstatreport.html#:~:text=New%20in%202020%2C%20the%20report,1%20in%203%E2%80%94have%20prediabetes. Accessed April 13, 2022.