Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain
- The Phase III trial AV001 aims to evaluate QUTENZA® in post-surgical neuropathic pain (PSNP), a debilitating complication of surgery occurring after approximately 10 percent of all surgical procedures[1], thus affecting more than 3 million people with surgical procedures per year in the U.S.[2]
- QUTENZA® is a topical system, non-systemic, non-opioid pain treatment that is currently approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.
- Topline results are expected in Q4 2025 and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data.
(Aachen, Germany, & Morristown, N.J.) – Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc., has completed recruitment for the Phase III clinical trial AV001. The trial investigates the efficacy, safety and tolerability of QUTENZA® (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) and if successful could support an extension of the U.S. label.
“Patients who undergo surgery and end up developing post-surgical neuropathic pain, may experience debilitating complications that often are not treated appropriately,” says Lizandra Marcondes, M.D., PhD, Senior VP Medical Affairs & Drug Safety US, Averitas Pharma. “We believe QUTENZA® may be a clinically meaningful treatment option that could address the unmet needs of many patients in the United States who suffer from Post-surgical neuropathic pain and may not be satisfied with available oral, systemically acting medicines. We look forward to completing the Clinical Trial with the goal to file a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in 2026, assuming positive data.”
AV001 is a randomized, double-blind 42 week trial including 410 patients who have been suffering from moderate to severe PSNP for at least six months. The primary endpoint of the trial is a reduction in the average pain intensity after 12 weeks compared to baseline. In addition, the trial assesses other outcomes including reduction in the average pain intensity after 42 weeks, progressive response over time with repeated treatment, reduction of the treatment area over several applications, and quality of life outcomes such as sleep interference, physical activity, anxiety, and depression. When completed, AV001 will be the first blinded randomized controlled trial in post-surgical neuropathic pain that evaluates the long term treatment effects of a topical neuropathic pain treatment.
“The completion of enrollment is an exciting milestone. With our current indications, adults with painful diabetic peripheral neuropathy of the feet and postherpetic neuralgia, we have advanced the trajectory of QUTENZA® in the U.S. by expanding access to a much-needed non-opioid therapy option for a large, underserved patient population,” adds Marv Kelly, President Averitas Pharma. “By adding post-surgical neuropathic pain to the U.S. label if results are positive, we would have the potential to fill an unmet treatment need for additional patients in pain.”
When Grünenthal acquired the US-rights for Qutenza® in 2018, the US-label comprised the treatment of neuropathic pain associated with postherpetic neuralgia. Since then, Grünenthal re-launched the product and significantly increased patients’ access to Qutenza®. In 2020, the U.S. FDA approved the product for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. With AV001, Grünenthal and Averitas hope to include another major indication in the field of peripheral neuropathic pain in the U.S. label. Topline results are anticipated in Q4 2025 and, assuming positive data, Averitas Pharma aims to submit a supplemental new drug application (sNDA) in 2026.
Follow us on:
LinkedIn: Grunenthal Group /
Instagram: grunenthal
IMPORTANT US-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.
1 Rosenberger DC, Pogatzki-Zahn EM. Chronic post-surgical pain - update on incidence, risk factors and preventive treatment options. BJA Educ. 2022 May;22(5):190-196. doi: 10.1016/j.bjae.2021.11.008. Epub 2022 Feb 24.
2 https://www.cdc.gov/nchs/fastats/inpatient-surgery.htm (Accessed November 2024)
3 ICD 11 - https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/985186256
Contacts
Christopher JansenGlobal Corporate Affairs
Tel:+49 241 569-1428Christopher.Jansen@grunenthal.comFlorian DieckmannHead Global Corporate Affairs
Tel:+49 241 569-2555Florian.Dieckmann@grunenthal.comAbout QUTENZA
QUTENZA (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia, and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important U.S. safety information is available below and at www.qutenza.com.
In Europe, QUTENZA is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain. For further information please visit www.grunenthalhealth.com.
About post-surgical neuropathic pain
Post-surgical neuropathic pain (PSNP) is defined as chronic pain that develops after a surgical procedure and persists beyond the healing process, i.e., at least three months after the surgery. The pain is either localized to the surgical field or area of injury, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues).[1] It is identified by symptoms of neuropathic nerve pain such as burning, stabbing or shooting pain, numbness, and changes to physical sensation or sensitivity to temperature or touch. PSNP occurs after approximately 10 percent of all surgical procedures1, thus affecting more than 3 million people with surgical procedures per year in the U.S.[2]
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.
Follow us on LinkedIn: https://www.linkedin.com/company/averitaspharma/
About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated 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 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 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion.
More information: www.grunenthal.com
Subscribe to releases from news aktuell GmbH
Subscribe to all the latest releases from news aktuell GmbH by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from news aktuell GmbH
Strategic investment in the future: Krombacher Brauerei modernises bottling plant with large-scale conversion21.11.2024 13:30:45 CET | Press release
Krombach, November 20th, 2024 Over the next six years, the Krombacher Brauerei is investing a total of over 100 million euros in the conversion of its bottling plant, in order to position itself for the future. With the largest and most extensive investment project in the company's long history, the brewery is not only emphasising its strong commitment to its home location, but also underlining its importance as one of the largest employers in the region.
Dubai Future Forum 2024: A Vision of Tomorrow, from Brain Chips to Climate Solutions21.11.2024 12:43:41 CET | Press release
(Dubai / the United Arab Emirates) – Scientists from over 100 countries, met this week at the Dubai Future Forum, the world’s largest gathering of futurists, to discuss the challenges ahead in a world, where technological innovation and artificial intelligence is shaping the future of humanity. They predicted revolutionary changes ahead that will pave the way people live, companies will be managed and the universe to be explored. New framework for innovation Innovation requires an adaptive framework, such as regulatory labs and sandbox systems, to foster technological progress while ensuring safety. “These systems and initiatives bring policymakers, entrepreneurs, and stakeholders together to collaborate and refine solutions,” explained Khalfan Belhoul, the CEO of Dubai Future Foundation. The technology supercycle will reshape the world, change corporate roles Three transformative technologies: Artificial intelligence (AI), biotechnology, and advanced sensors are expected to profoundly
RESULTS OF THE MAIRE FOUNDATION STUDY AT COP29 IN BAKU: PEOPLE IN AZERBAIJAN AND KAZAKHSTAN AWARE OF THE URGENCY OF THE ENERGY TRANSITION20.11.2024 12:02:32 CET | Press release
55% of Azerbaijani respondents say that the energy transition is a priority, in line with European countries 64% of Azerbaijani respondents (more than the United Arab Emirates, Saudi Arabia and India) and 53% in Kazakhstan (more than Italy, the United Kingdom, the United States and China itself) consider energy transition crucial to combat climate change Energy transition training and professional development are crucial issues in both Kazakhstan and Azerbaijan for over 80% of those interviewed, more than in India (71%), USA and Saudi Arabia (75%) The study covers 12 countries in 4 continents for a total of over 2,000 interviews carried out by IPSOS, an international market research company
GEMA: GEMA files model action to clarify AI providers‘ remuneration obligations in Europe13.11.2024 11:19:58 CET | Press release
GEMA is the first collecting society worldwide to file a lawsuit against a provider of generative artificial intelligence (AI) systems for the unlicensed use of protected musical works. Specifically, it concerns the US company OpenAI, the autogenerative chatbot systems operator. GEMA accuses OpenAI of reproducing protected song lyrics by German authors without having acquired licenses or paid the authors in question. The aim is to prove that OpenAI systematically uses GEMA's repertoire to train its systems.
HEIDELBERG anticipates a very strong second half to financial year 2024/202513.11.2024 08:53:36 CET | Press release
Incoming orders after six months above previous year’s level thanks to strong drupa orders High order backlog provides sound basis for projected sales volume in second half of the year, capacities being fully utilized Strong seasonality in financial year, with sales and EBITDA in the first half of the year within expectations Packaging solutions segment remains growth driver Annual forecast confirmed
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom