Grünenthal and Averitas Pharma announce initiation of Phase III study with QUTENZA®

• Post-surgical neuropathic pain (PSNP) is a debilitating complication of surgery that affects approximately 13 percent of all patients who undergo surgery, which represents 3.3 million patients per year in the US.[1]
• This Phase III study is Grünenthal’s next step in making QUTENZA available to even more patients in the United States. QUTENZA is the first and only prescription strength capsaicin that is a topical, non-systemic, non-opioid pain treatment; it is currently 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.

Aachen, Germany, & Morristown, N.J., 30 March 2021 – Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc. will conduct a Phase III trial to study the efficacy, safety and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) with the goal to expand the current U.S. product label. The randomised, double-blind trial AV001 will include between 400 and 500 patients who have been suffering from moderate to severe PSNP for at least six months, and aims to demonstrate a significant reduction in the average pain intensity after 12 weeks and 42 weeks compared to the baseline. In addition, the trial will assess other outcomes like progressive response over time with repeated application, reduction of the treatment area over several applications, and Quality of Life outcomes such as sleep interference, physical activity, anxiety and depression. First patients are expected to be enrolled in the third quarter of 2021 with trial completion expected in 2024. 

“A significant number of patients suffer from burning, stabbing or shooting neuropathic pain as a complication of surgery. Commonly used oral, systemically acting medicines often provide unsatisfactory results or are accompanied by considerable side effects,” says John Douglas Markman, M.D., coordinating investigator and Professor for Neurosurgery at the University of Rochester School of Medicine and Dentistry. “Averitas is conducting the first double-blind study in PSNP that will explore long-term safety and efficacy in patients with a much-needed non-systemic, non-opioid treatment option.”

In July 2020, Grünenthal significantly expanded the reach of QUTENZA in the United States by expanding the label to include the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. This complication of diabetes affected more than 5 million Americans in 2020[2], and the number of affected patients is expected to double by 2030[3].

“The label extension was a major milestone for our U.S. business and made QUTENZA accessible for millions of adult patients who suffer from painful DPN of the feet”, says Gabriel Baertschi, CEO Grünenthal. “More than one in ten patients who undergo surgery are affected by PSNP, and we believe that QUTENZA, a topical, non-opioid pain treatment, could provide a meaningful therapy option. With the new Phase III study in PSNP, we are confident to make QUTENZA available to even more patients.”

About QUTENZA

QUTENZA offers physicians a different way to  treat neuropathic pain associated with PHN or DPN of the feet in adults. QUTENZA, a specially formulated topical system, delivers prescription strength capsaicin directly to the skin during an in-office procedure. In this way, it can reversibly desensitise and defunctionalize the TRPV1 (Transient Receptor Potential Vanilloid 1) receptor, which plays a critical role in pain signalling.

QUTENZA administered as a single localised procedure can provide sustained pain relief that lasts for up to three months. It has no known drug-drug interactions. The most common adverse reactions include application site reactions, such as erythema, pain, and pruritus. The majority of application site reactions were transient and self-limited.[4] 

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

Chronic post-surgical pain 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 localised 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).[5] Chronic post-surgical pain is the result of nerve damage and can be due to the surgery itself or other causes of pain including infection, malignancy, etc. 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. Post-surgical neuropathic pain affects approximately 13 percent of all patients undergoing surgery, which represents 3.3 million patients per year in the US.[1]

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 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

More information: www.grunenthal.com

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[1] Classifying surgeries were factored against their respective time-bound frequency of PSNP to yield the prevalence based on:

• Carroll, I. R., Hah, J. M., Barelka, P. L., Wang, C. K. M., Wang, B. M., Gillespie, M. J., … Mackey, S. C. (2015). Pain Duration and Resolution following Surgery: An Inception Cohort Study. Pain Medicine, 16(12), 2386–2396. doi:10.1111/pme.12842.
• Shipton, E. (2008). POST-SURGICAL NEUROPATHIC PAIN. ANZ Journal of Surgery, 78(7), 548–555. doi:10.1111/j.1445-2197.2008.04569.x
• Borsook, D., Kussman, B. D., George, E., Becerra, L. R., & Burke, D. W. (2013). Surgically Induced Neuropathic Pain. Annals of Surgery, 257(3), 403–412. doi:10.1097/sla.0b013e3182701a7b.

[2] LTP 2020-2030: Addressable populations by condition (PDPN, PSNP, PHN, CINP). Company data on file. April 30, 2020.

[3] 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.

[4] QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma.

[5] ICD 11 - https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/985186256

For further information, please contact:

Fabia Kehren, Head External Communications & Editorial Management

Phone: +49 241 569-3269

Fabia.Kehren@grunenthal.com

Florian Dieckmann, Head Global Communications

Phone: +49 241 569-2555

Florian.Dieckmann@grunenthal.com