- The study AV001 goals to incorporate the remedy of post-surgical neuropathic pain (PSNP) in the U.S. label. QUTENZA® is at the moment accepted to be used in adults in the remedy of neuropathic pain related with postherpetic neuralgia and for the remedy of neuropathic pain related with diabetic peripheral neuropathy (DPN) of the toes.
- Post-surgical neuropathic pain is a debilitating complication of surgical procedure that impacts roughly 13% of all sufferers who endure surgical procedure, representing 3.3 million sufferers per yr in the US.
Aachen, Germany, & Morristown, N.J., 10 August 2021 – Grünenthal introduced immediately that its U.S. subsidiary, Averitas Pharma Inc., enrolled the primary patient in the randomised, double-blind trial AV001. The Phase III study investigates the efficacy, security, and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) to help an extension of the U.S. label.
The trial will embrace over 400 sufferers who are suffering from reasonable to extreme power PSNP for at the very least six months and is being carried out throughout greater than 70 websites in Europe and the U.S. The trial goals to display a vital discount in the typical pain depth after 12 weeks and after 42 weeks in comparison with baseline. In addition, the trial will assess different outcomes reminiscent of progressive response over time with repeated software, discount of the remedy space over a number of purposes, and high quality of life points reminiscent of sleep interference, bodily exercise, nervousness, and melancholy. The completion and subsequent supplemental new drug software submission are anticipated in 2024.
“We believe that QUTENZA, a non-opioid and non-systemic topical system, is a meaningful treatment option and continuously work to increase its footprint,” says Jan Adams, M.D., Chief Scientific Officer Grünenthal. “We want to provide patients in the U.S. who suffer from PSNP access to QUTENZA and make progress towards our vision of a world free of pain.”
Continuous improvement of the QUTENZA US label
Grünenthal acquired the worldwide rights for QUTENZA in November 2018. At this level, the U.S. label for QUTENZA comprised the remedy of neuropathic pain related with postherpetic neuralgia. Since then, Grünenthal had labored constantly to make the product obtainable to extra individuals in the U.S. and achieved a vital label extension when the FDA accepted QUTENZA for the remedy of neuropathic pain related with diabetic peripheral neuropathy (DPN) of the toes in adults in July 2020. Through the brand new study AV001, Grünenthal strives to incorporate one other main indication in the sphere of peripheral neuropathic pain in the U.S. label.
QUTENZA presents physicians a totally different option to deal with neuropathic pain related with PHN or DPN of the toes in adults. QUTENZA, a specifically formulated topical system, delivers prescription-strength capsaicin on to the pores and skin throughout an in-office process. This manner, it may well reversibly desensitise and defunctionalise the TRPV1 (Transient Receptor Potential Vanilloid 1) receptor, which performs a crucial position in pain signalling.
QUTENZA administered as a single localised process can present sustained pain aid that lasts for as much as three months. It has no recognized drug-drug interactions. The most typical antagonistic reactions embrace software web site reactions, reminiscent of erythema, pain, and pruritus. The majority of software web site reactions have been transient and self-limited.
QUTENZA (capsaicin) 8% topical system is accepted in the US for the remedy of neuropathic pain related with postherpetic neuralgia, and for the remedy of neuropathic pain related with diabetic peripheral neuropathy (DPN) of the toes in adults. Important U.S. security data is obtainable under and at www.qutenza.com.
In Europe, QUTENZA is indicated for the remedy of peripheral neuropathic pain in adults both alone or in mixture with different medicinal merchandise for the remedy of pain. For additional data, please go to www.grunenthalhealth.com.
About post-surgical neuropathic pain
Chronic post-surgical pain is outlined as power pain that develops after a surgical process and persists past the therapeutic course of, i.e. at the very least three months after the surgical procedure. The pain is both localised to the surgical discipline or space of damage, projected to the innervation territory of a nerve located in this space, or referred to a dermatome (after surgical procedure/damage to deep somatic or visceral tissues). Chronic post-surgical pain is the results of nerve injury and will be as a result of surgical procedure itself or different causes of pain together with an infection, malignancy, and many others. It is recognized by signs of neuropathic nerve pain reminiscent of burning, stabbing or taking pictures pain, numbness and modifications to bodily sensation or sensitivity to temperature or contact. Post-surgical neuropathic pain impacts roughly 13 % of all sufferers present process surgical procedure, which represents 3.3 million sufferers per yr in the US.
 Classifying surgical procedures have been factored in opposition to their respective time-bound frequency of PSNP to yield the prevalence based mostly on:
- Carroll, I. R., Hah, J. M., Barelka, P. L., Wang, C. Okay. 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.
 QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma.
About Averitas Pharma, Inc.
Averitas Pharma is a specialty pharmaceutical firm devoted to delivering revolutionary, efficient, non-opioid pain administration choices to sufferers in the U.S. The firm was fashioned in 2018, as a subsidiary of GRT U.S. Holding, Inc. and member of the Grünenthal Group. For extra data, go to www.averitaspharma.com.
Grünenthal is a world chief in pain administration and associated illnesses. As a science-based, privately-owned pharmaceutical firm, now we have a lengthy observe document of bringing revolutionary remedies and state-of-the-art applied sciences to sufferers worldwide. Our objective is to alter lives for the higher – and innovation is our ardour. We are focusing all of our actions and efforts on working in direction of our imaginative and prescient of a world freed from pain.
Grünenthal is headquartered in Aachen, Germany, and has associates in 29 international locations throughout Europe, Latin America and the US. Our merchandise can be found in greater than 100 international locations. In 2020, Grünenthal employed round 4,500 individuals and achieved gross sales of € 1.3 bn.
More data: www.grunenthal.com
For additional data, please contact:
Christopher Jansen, Communication Business Partner
Phone: +49 241 569-1428
Florian Dieckmann, Head Global Communications
Phone: +49 241 569-2555
QUTENZA® (capsaicin) 8% topical system is indicated in adults for the remedy of neuropathic pain related with postherpetic neuralgia (PHN) and for neuropathic pain related with diabetic peripheral neuropathy (DPN) of the toes.
IMPORTANT US-SAFETY INFORMATION
Do not dispense QUTENZA to sufferers for self-administration or dealing with. Only physicians or healthcare professionals below the shut supervision of a doctor are to manage and deal with QUTENZA.
When administering QUTENZA, you will need to observe the procedures in the Important Dosage and Administration Instructions in the US Prescribing Information.
In sufferers handled for neuropathic pain related with diabetic peripheral neuropathy of the toes, a cautious examination of the toes must be undertaken prior to every software of QUTENZA to detect pores and skin lesions associated to underlying neuropathy or vascular insufficiency.
Warnings and Precautions
- Unintended publicity to capsaicin could cause extreme irritation of eyes, mucous membranes, respiratory tract, and pores and skin in healthcare professionals, sufferers, and others. Healthcare professionals ought to be sure that the really helpful procedures and protecting measures are used when administering QUTENZA.
- For healthcare professionals, put on nitrile gloves when administering QUTENZA and keep away from pointless contact with objects in the room, together with objects that the patient might later have contact with, reminiscent of horizontal surfaces and bedsheets.
- Do not apply QUTENZA to the patient’s face, eyes, mouth, nostril, or scalp to keep away from danger of publicity to eyes or mucous membranes. Accidental publicity to the eyes and mucous membranes can happen from touching QUTENZA, or objects uncovered to capsaicin, after which touching the eyes and mucous membranes. If irritation of eyes or mucous membranes happens, flush eyes and mucous membranes with cool water. Remove the affected person (healthcare skilled or patient) from the neighborhood of QUTENZA.
- Aerosolization of capsaicin can happen upon speedy removing of QUTENZA. Therefore, take away QUTENZA gently and slowly by rolling the adhesive aspect inward. Inhalation of airborne capsaicin may end up in coughing or sneezing. Administer QUTENZA in a well-ventilated remedy space. Provide supportive medical care if shortness of breath develops. If irritation of airways happens, take away the affected person from the neighborhood of QUTENZA. If respiratory irritation worsens or doesn’t resolve, don’t re-expose the affected healthcare skilled or patient to QUTENZA.
- If pores and skin not supposed to be handled is uncovered to QUTENZA, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the world with cleaning soap and water.
- Patients might expertise substantial procedural pain and burning upon software and following removing of QUTENZA. Prepare to deal with acute pain throughout and following the applying process with native cooling (reminiscent of a chilly pack) and/or acceptable analgesic treatment.
- Transient will increase in blood stress might happen throughout and shortly after QUTENZA remedy. Blood stress modifications have been related with treatment-related will increase in pain. Monitor blood stress and supply satisfactory help for treatment-related pain. Patients with unstable or poorly managed hypertension, or a latest historical past of cardiovascular or cerebrovascular occasions, could also be at an elevated danger of antagonistic cardiovascular results. Consider these elements previous to initiating QUTENZA remedy.
- Reductions in sensory perform have been reported following administration of QUTENZA. Decreases in sensory perform are typically minor and short-term. All sufferers with pre-existing sensory deficits must be clinically assessed for indicators of sensory deterioration or loss prior to every software of QUTENZA. If sensory deterioration or loss is detected, or pre-existing sensory deficit worsens, continued use of QUTENZA remedy must be reconsidered.
In all managed scientific trials, antagonistic reactions occurring in ≥5% of sufferers in the QUTENZA group, and at an incidence at the very least 1% larger than in the management group, have been software web site erythema, software web site pain, and software web site pruritus.
Adverse Event Reporting
Physicians, different healthcare suppliers, and sufferers are inspired to voluntarily report antagonistic occasions involving medicine or medical gadgets. To make a report you’ll be able to:
- In the U.S., go to www.fda.gov/medwatch or name 1-800-FDA-1088; or
- For QUTENZA, you might also name 1-877-900-6479 and choose possibility 1, or press zero in your keypad to speak to an operator to direct your name.
Please see full US Prescribing Information.
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