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
Poundland’s Last-Minute Rescue Deal
Poundland is pursuing a rescue deal to avoid collapse amid financial woes, affecting UK retailers.
Poundland is in a critical situation as it seeks a last-minute rescue deal to prevent its collapse. The British retailer, unable to purchase new stock due to severe financial constraints, faces an uncertain future. This development, reported on November 11, 2026, underscores a challenging period for the company and highlights broader issues impacting UK high street retailers. The potential failure of such a well-known brand has raised significant concerns about the health of the retail sector.
Gordon Brothers, a potential suitor for Poundland, is actively involved in efforts to secure a rescue deal. The firm is urging the release of necessary funding to finalise the sale, which is seen as vital to ensure the retailer’s survival. This move is not just about saving Poundland but also about stabilising confidence in the sector that has been increasingly under pressure. The stakes are high, and the outcome remains crucial not only for the company but for its employees and the wider retail landscape.
The urgency of the situation cannot be overstated. Poundland’s inability to secure new stock due to its financial woes is a direct consequence of deeper issues plaguing the retail industry. This predicament has sparked fears of a complete collapse, which would have significant repercussions for employees and consumers reliant on the affordability and convenience of Poundland stores. The retailer’s plight is a stark reminder of the precarious position of many high street brands in the current economic climate.
The broader trend of financial struggles among UK retailers is evident, as noted by Sky News. Poundland’s situation is emblematic of the pressures facing many high street businesses today. Rising costs, changing consumer habits, and intense competition from online retailers have created a perfect storm, threatening the survival of traditional brick-and-mortar establishments. The outcome of Poundland’s rescue deal could set a precedent for how other struggling retailers navigate similar challenges.
As the situation unfolds, the focus remains on whether the necessary funding and agreements can be secured in time to save Poundland. The company’s future hangs in the balance, and the need for a decisive resolution is paramount. The involvement of Gordon Brothers adds a layer of potential optimism, but the complex nature of retail financing means the path to a successful deal is fraught with uncertainty.
The implications for UK high street retailers are significant. A collapse of Poundland could signal further instability, shaking consumer confidence and potentially leading to a domino effect among other retailers. Conversely, a successful rescue could provide a much-needed boost to the sector, offering a template for similar deals in the future. The retail industry will be closely watching the developments, as the outcome will likely influence strategic decisions across the market.
In conclusion, Poundland’s pursuit of a rescue deal is a critical moment for the retailer and the broader industry. The company’s ability to navigate this challenging period will depend heavily on the outcome of negotiations with Gordon Brothers and the timely release of funds. As of now, all eyes are on this high-stakes situation, and the coming days will be decisive. The retail sector’s trajectory may well hinge on the resolution of this pressing financial dilemma.
Business & Finance
Paraguay President Santiago Peña Resigns Amid Bank Collapse
Paraguay’s President Santiago Peña resigns amid a bank collapse impacting millions, sparking a major financial crisis.
On November 5, 2026, Paraguay’s political landscape was dramatically reshaped as President Santiago Peña resigned amid a severe financial crisis. This crisis, characterized by the collapse of a major bank, has left millions of Paraguayans with frozen savings, triggering widespread financial instability across the nation [The Guardian, November 2026]. The resignation came after intense public pressure, reflecting the profound impact of the banking sector’s failure on the country’s socio-economic fabric [The Guardian, November 2026].
The immediate catalyst for Peña’s resignation was the unprecedented bank failure that exposed significant vulnerabilities in Paraguay’s financial system. This collapse not only froze millions of savings but also drew international scrutiny to the country’s fiscal management [BBC, November 2026]. The banking debacle underscored the systemic issues within Paraguay’s financial institutions, raising questions about regulatory oversight and governance that have yet to be fully addressed.
Peña’s decision to step down was formally communicated through an official announcement, marking a pivotal moment in Paraguay’s political history [BBC, November 2026]. This move was largely seen as a response to growing unrest and a loss of confidence in his administration’s ability to manage the crisis effectively. The president’s resignation has opened a leadership vacuum at a critical juncture, as the nation grapples with stabilizing its economy and restoring public trust.
The international community has been closely monitoring the developments in Paraguay, with the bank collapse serving as a cautionary tale of financial mismanagement [BBC, November 2026]. While specific international responses were not detailed, the situation has likely prompted discussions on the need for stronger financial governance frameworks in similar emerging markets. The crisis has highlighted the interconnectedness of global financial systems and the potential repercussions of inadequate oversight.
As Paraguay faces this economic turmoil, the focus now shifts to the interim leadership and their strategies to mitigate the crisis’s impact. Restoring the public’s access to their frozen assets will be a priority, alongside implementing reforms to prevent future financial collapses. The path forward will require decisive action from both domestic policymakers and international financial bodies to ensure stability and confidence in Paraguay’s banking sector.
The ripple effects of this financial crisis extend beyond Paraguay, as regional economies assess their vulnerabilities to similar shocks. The need for robust risk management practices and transparency in financial dealings is underscored by this situation. Paraguay’s experience may serve as a catalyst for broader financial reforms within the region, promoting resilience against potential economic disruptions.
The coming weeks will be crucial in determining the effectiveness of Paraguay’s response to the crisis. The interim leadership’s ability to navigate these challenges will set the tone for the country’s economic recovery and political stability. Observers will be keenly watching for signs of progress as Paraguay seeks to rebuild its financial credibility and restore normalcy for its citizens.
Peña’s resignation, though a significant political event, is just the beginning of a complex recovery process for Paraguay. The nation’s future hinges on its capacity to implement necessary reforms and regain the confidence of both its people and the international community. The lessons learned from this crisis will likely inform future policy decisions, shaping Paraguay’s path toward economic resilience.
In the aftermath of this crisis, Paraguay’s financial system will inevitably undergo scrutiny and transformation. The global financial community will be attentive to how Paraguay addresses its systemic issues, with the potential for this situation to become a case study in crisis management and reform. The developments in Paraguay may influence how emerging economies structure their financial governance in the years to come.
Business & Finance
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FBI attributes $6.3B Binance crypto hack to North Korea, raising security concerns. Binance covers 90% of losses.
In a striking attribution of cyber malfeasance, the Federal Bureau of Investigation has named North Korea as the perpetrator behind a colossal $6.3 billion hack on Binance, one of the world’s largest cryptocurrency exchanges. This revelation underscores persistent cybersecurity vulnerabilities and intensifies geopolitical tensions already fraught with complexity [The Guardian, November 2026].
The breach, now recognized as the largest of its kind, has sent shockwaves through the digital asset community, raising urgent questions about the robustness of current security protocols within the crypto industry [Al Jazeera, November 2026]. Despite the significant financial blow, Binance has demonstrated resilience by covering a substantial 90% of the losses, reflecting its commitment to maintaining user trust and stability [The Guardian, November 2026].
Binance’s response to the hack has been proactive, involving collaboration with international law enforcement agencies to pursue recovery of the stolen assets. A spokesperson from the exchange affirmed, “We are working closely with law enforcement to recover the funds,” indicating a strategic approach to mitigate the consequences of this unprecedented breach [The Guardian, November 2026].
The scale of the hack, valued at $6.3 billion, places it squarely in the spotlight of global financial and security discussions. It serves as a stark reminder of the vulnerabilities inherent in digital finance systems, particularly as they become more entwined with global economic infrastructures [Al Jazeera, November 2026].
North Korea’s involvement in such a high-profile cybercrime reflects broader geopolitical dynamics, where state-sponsored hacking has become a tool for economic gain and political leverage. This attribution by the FBI further complicates diplomatic relations and underscores the need for coordinated international responses to cyber threats [The Guardian, November 2026].
The incident has not only affected Binance but has also sent ripples across the broader cryptocurrency market, prompting investors and exchanges to reassess their security measures. The hack’s magnitude highlights the urgent need for enhanced protective measures and industry-wide collaboration to fortify digital asset exchanges against future threats [Al Jazeera, November 2026].
In the wake of this cyber assault, Binance’s robust response and coverage of losses may set a precedent for how exchanges handle such adversities in the future. It also emphasizes the critical role of transparency and accountability in maintaining user confidence and market integrity [The Guardian, November 2026].
As the situation unfolds, the interplay between cybersecurity and international politics will likely intensify, with potential repercussions for regulatory frameworks governing digital assets. The hacking incident serves as a catalyst for ongoing debates about the balance between innovation and security in the realm of cryptocurrency [Al Jazeera, November 2026].
Looking forward, the focus will remain on how Binance and other cryptocurrency platforms adapt to these evolving threats. Their ability to enhance security protocols and foster international cooperation will be crucial in defining the future landscape of digital finance. The world will closely monitor these developments, particularly as they relate to North Korea’s cyber capabilities and intentions [The Guardian, November 2026].
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