Business & Finance
Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain
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- 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., 7 November 2024 – 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.
About 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).[3]
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
Follow us on:
LinkedIn: Grunenthal Group /
Instagram: grunenthal
For further information, please contact:
|
Christopher Jansen, Global Corporate Affairs Phone: +49 241 569-1428 Florian Dieckmann, Head Global Corporate Affairs Phone: +49 241 569-2555 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
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
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Business & Finance
How AI is Transforming Small Businesses: Success Stories
This article explores the transformative impact of AI on small enterprises, highlighting specific case studies of businesses that have successfully integrated AI technologies to enhance efficiency and competitiveness.
In September 2026, the Financial Times reported a significant surge in the adoption of AI technologies by small enterprises, driven by the promise of enhanced efficiency and reduced operational costs. Among the many businesses venturing into this digital frontier, a few stand out as exemplary cases, demonstrating the transformative power of AI when strategically implemented.
Take, for instance, GreenLeaf Grocers, a small organic food retailer based in Brighton. Faced with the challenges of scaling operations and managing inventory efficiently, GreenLeaf turned to AI-driven inventory management systems. By analyzing customer purchasing patterns and forecasting demand, the system enabled the grocer to optimize stock levels, reducing waste by 30% within the first year. The owner, Sarah Jenkins, noted, “AI has not only streamlined our operations but has also allowed us to focus more on customer service and community engagement.” This case underscores the potential of AI to reshape retail operations, offering insights into customer behavior that were previously inaccessible.
Another compelling story is that of TechFixers, a family-run electronics repair shop in Manchester. Confronted with increasing competition and the need to differentiate their services, the owners implemented an AI-powered diagnostic tool. This technology rapidly identifies device issues, providing technicians with precise solutions. As a result, TechFixers reduced average repair times by 40%, significantly boosting customer satisfaction and expanding their clientele. The owner, Mark Thompson, attributes their competitive edge to AI, stating, “Integrating AI into our diagnostic process has been a game-changer, allowing us to offer quicker, more reliable repairs.”
In the realm of financial services, FinServe, a small accounting firm in London, illustrates the impact of AI on service delivery. By employing AI-based analytics tools, FinServe offers clients real-time financial insights and predictive forecasting. This capability has attracted a new segment of tech-savvy clients seeking proactive financial management. The firm’s director, Lucy Patel, emphasized the strategic advantage gained, “AI has empowered us to provide a level of service that was previously the domain of larger firms. We’re now able to deliver insights and strategic advice that truly add value for our clients.”
These cases highlight not only the successful application of AI in various industries but also the diverse ways in which small enterprises can leverage technology to overcome specific challenges. While the potential benefits of AI are substantial, the journey is not without its hurdles. Businesses must navigate the complexities of data integration, system compatibility, and the initial investment costs. However, for those willing to embrace the change, the rewards can be substantial.
As AI technology continues to evolve, its role in small business operations is likely to expand, offering new opportunities for innovation and growth. The experiences of GreenLeaf Grocers, TechFixers, and FinServe serve as a testament to the transformative power of AI, providing a roadmap for other small enterprises eager to harness this technology.
Looking ahead, the integration of AI into small business operations is set to become even more pervasive. As technology advances and becomes more accessible, businesses of all sizes will find new ways to leverage AI for competitive advantage, creating a dynamic and constantly evolving landscape.
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In September 2026, the European Union unveiled a comprehensive regulatory framework for cryptocurrencies, marking a pivotal moment in the evolution of digital finance. These new regulations are designed to foster market transparency and enhance investor confidence, setting a precedent that could influence global cryptocurrency policies. The framework, announced by the European Commission, aims to address the volatility and unpredictability that have long plagued the cryptocurrency markets. By implementing stringent disclosure requirements and robust consumer protection measures, the EU seeks to create a safer and more stable environment for both seasoned investors and new entrants.
At the heart of the new regulations are provisions that require cryptocurrency exchanges and wallet providers to adhere to strict transparency standards. This includes mandatory reporting of transaction data and enhanced identity verification processes, which aim to curb illegal activities such as money laundering and fraud. According to the European Commissioner for Financial Services, Mairead McGuinness, these measures will not only protect investors but also bolster the legitimacy of the cryptocurrency market as a whole.
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Looking ahead, the EU’s regulatory framework is poised to redefine the cryptocurrency landscape, with potential ripple effects across the globe. As other jurisdictions observe the EU’s progress, they may be inspired to implement similar measures, ultimately contributing to a more transparent and secure global financial system. In this new era, the balance between regulation and innovation will be key to unlocking the full potential of cryptocurrencies.
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In a decisive move aimed at curbing the dominance of technology giants, the European Union has implemented a suite of new regulations designed to foster competition and innovation within the industry. Announced by the European Commission on May 21, 2026, these measures are part of a broader strategy to dismantle monopolistic practices and empower smaller players in the tech sector. The Financial Times reported that this regulatory shift could herald a new era for startups and small businesses, offering them a unique opportunity to compete on a more level playing field.
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