Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain
Comunicato Precedente
Comunicato Successivo
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
[email protected]
Florian Dieckmann, Head Global Corporate Affairs
Phone: +49 241 569-2555
[email protected]
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
View original content:
