Astellas Announces Results from the First Head to Head Study Comparing QUTENZATM (Capsaicin 8% Patch) with Current Standard of Care in Patients with Peripheral Neuropathic Pain
Astellas Pharma Europe Ltd. today announced the publication in the European Journal of Pain of a head to head, non-inferiority study that compared the capsaicin 8% patch (QUTENZATM) with pregabalin capsules (flexible, optimised dose) in adult patients with peripheral neuropathic pain (PNP)1. The authors conclude that the capsaicin 8% patch provided non-inferior pain relief compared with pregabalin, in addition to a shorter median time to pain relief, fewer systemic side effects and greater treatment satisfaction.1
The ELEVATE study* had a randomised, open-label, 8-week, non-inferiority design and included 559 adults with moderate-to-severe PNP. Patients were randomised to receive either a single treatment with the capsaicin 8% patch or daily administration of an optimised dose of oral pregabalin. The study met its primary endpoint of non-inferiority for pain relief, defined by a ≥30% decrease in mean numeric pain rating scale (NPRS) score from baseline to Week 8.1 The 30% responder rate was 55.7% in the capsaicin 8% patch arm, compared with 54.5% in the pregabalin arm (odds ratio [95% CI]: 1.03 [0.71, 1.50]).1 Moreover, the median time to pain relief with the capsaicin 8% patch was 7.5 days, compared with 36.0 days [including titration period] with pregabalin (hazard ratio [95% CI]: 1.68 [1.35, 2.08]; p<0.0001).1
Commenting on the results of ELEVATE, Professor Maija Haanpää, Principal Study Investigator, Department of Neurosurgery, Helsinki University Central Hospital, Helsinki, Finland said: “This is an important and well-conducted study that was designed to mimic everyday practice, allowing those patients randomised to the pregabalin arm to be individually titrated to the optimal tolerated dose. We found that topical treatment with the capsaicin 8% patch was non-inferior to the current standard of care. This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day.”
Secondary endpoints included optimal therapeutic effect (assessed using a composite endpoint including pain relief, adverse events and treatment discontinuation), median time to pain relief (defined as when 50% of patients had a 30% reduction in NPRS score) and treatment satisfaction.1 Results showed a difference in patient perception of treatment effectiveness, side effects and treatment satisfaction that were in favour of the capsaicin 8% patch.1
“Some patients may still receive inadequate pain management and have to balance effective pain relief and the side effects of their medication. The capsaicin 8% patch is applied topically and hence has shown less systemic side effects than seen with oral medications. There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain,” commented Dr Andreas Karas, Senior Director, Medical Affairs, Astellas Pharma EMEA.
The proportion of drug-related treatment emergent adverse events (TEAEs) was 54.5% for pregabalin and 61.3% for the capsaicin 8% patch.1 TEAEs leading to permanent discontinuation of study drug were only reported in the pregabalin arm (n=24, 8.5%).1 With the capsaicin 8% patch, the majority of drug-related TEAEs were transient and related to the application site.1 In comparison, pregabalian was associated with systemic adverse drug reactions (ADRs).1 Systemic ADRs ranged from 0-1.1% for the capsaicin patch and 2.5-18.4% for pregabalin.1
In September this year, the European Commission granted approval for a label extension for QUTENZATM (capsaicin 8% patch) for the treatment of peripheral neuropathic pain in adults, including adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain.2
– Ends –
Notes to Editors
About neuropathic pain
Neuropathic pain, a type of pain caused by a lesion or disease of the somatosensory nervous system,3 is a well-characterised neurological condition, which has been estimated to affect approximately 7–8% of the general population in Europe.4,5 The pain intensity varies and can impact a person’s quality of life, general health and social and economic wellbeing.6
About QUTENZA ™ (capsaicin 8% patch)
The capsaicin 8% patch is approved by the European Medicines Agency for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.2 The capsaicin 8% patch is approved for use in 27 countries across Europe as of the end of 2014.
The capsaicin 8% patch delivers a high-dose of a synthetic form of capsaicin directly to the damaged pain sensing nerves in the skin that are the source of neuropathic pain. Applied to the area of pain, the high concentration of capsaicin contained in the patch is released into the skin where it overstimulates the pain sensing nerves. Overstimulating the pain sensing nerves makes them become “defunctionalised,” effectively reducing their spontaneous activity and making them unresponsive to stimuli that normally cause pain for patients with peripheral neuropathic pain.7 As a result of treatment-related discomfort, transient increases in blood pressure may occur during and shortly after treatment with the capsaicin 8% patch.8 There have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches.9
Important information for the capsaicin 8% patch, including safety information, is included in the full Summary of Product Characteristics at: https://www.medicines.org.uk/emc/medicine/23156.
Astellas Pharma Europe Ltd. operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas’ presence in Europe also includes an R&D site and three manufacturing plants.
1. Haanpää M, et al. Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain. European Journal of Pain, 2015; epub ahead of print. doi:10.1002/ejp.731
2. QUTENZATM, Summary of Product Characteristics. Available from: http://www.medicines.org.uk/emc/medicine/23156 (Accessed November 2015).
3. Jensen, Troels S, et al. A new definition of neuropathic pain. Pain 2011;152(10):2204-5.
4. Torrance N, et al. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain 2006;7:281-289.
5. Bouhassira D, et al. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain 2008;136:380-387.
6. NICE clinical guidelines 173 Neuropathic Pain – pharmacological management in non-specialist settings. November 2013. Available from: https://www.nice.org.uk/guidance/cg173/chapter/Introduction (Accessed November 2015).
7. Anand P et al. Topical capsacin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth 2011;107(4):490-502.
8. Backonja M, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008;7(12):1106-12.
9. European Medicines Agency (EMA). Qutenza European Public Assessment Report (EPAR). Doc. Ref.: EMEA/629172/2009 EMEA/H/C/909. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000909/WC500040448.pdf. (Accessed November 2015).
* Trial registration: ClinicalTrials.gov Identifier: NCT01713426
Astellas Pharma EMEA
+44 (0)7768 424046
Red Door Unlimited
+44 (0)208 392 8091
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Proton OnSite Has Been Awarded a Contract for Approximately USD 1.8 Million and Assumes the Lead Role in the US Government Advanced Water Splitting Benchmarking Project23.10.2017 21:02 | Pressemelding
Proton OnSite (Proton), a wholly owned subsidiary of Nel ASA, Oslo Norway (Nel, OSE:NEL) has been awarded a contract for approximately USD 1.8 million to participate in the US Department of Energy’s (DOE’s) Advanced Water Splitting Benchmarking Project. This is a critical piece of DOE’s HydroGEN Energy Materials Network (EMN) consortium, which was launched to accelerate the discovery and development of materials for low cost hydrogen production, enabling energy storage, resiliency and economic opportunities across sectors. Proton will work with DOE National Laboratories and lead a team to ensure that all experimental results across the water splitting research community are properly vetted, standards are set for comparison, and roadmaps are developed including research priorities and capability needs. Kathy Ayers, Proton’s Vice President of Research and Development, has been named overall project
SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico23.10.2017 17:14 | Pressemelding
SES Networks' high throughput and fibre-like satellite connectivity service, the stratospheric balloons operated by X, Alphabet’s self-described “moonshot factory”, and local telecommunications expertise are playing a key role in restoring 4G/LTE connectivity in disaster-affected Puerto Rico, SES announced today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023006165/en/ SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico (Photo: Business Wire) The connectivity is powered by Project Loon's targeted cell coverage and SES Networks' O3b FastConnect, a rapidly deployable satellite terminal delivering fibre-like performance. Together with local technology partners, SES Networks and X are providing reliable high-performance connectivity to Puerto Ricans whose lives have been dev
Sagemcom Unveils the Next-Generation Multi-Gigabit Solutions23.10.2017 16:05 | Pressemelding
AFTER THE SUCCESS OF ITS ONE GIGABIT GATEWAY RANGE, SAGEMCOM RELEASES TO THE OPERATORS THE NEXT GENERATION MULTI-GIGABIT GATEWAYS – VDSL 35B / G.FAST / PON, 2.5G/10G PON, DOCSIS 3.1 – INTEGRATING HIGH EFFICIENCY 802.11AX Wi-Fi, IN ADDITION TO NEW SMART HOME CONNECTIVITY SOLUTIONS INCLUDING DISTRIBUTED WI-FI, VOICE CONTROL AND HOME AUTOMATION. The VDSL 35B / G.fast / FTTH / PON universal gateway, F@st 5380, integrates G.fast 212MHz, GPON and 802.11ax Wi-Fi, enabling the operators to deliver Multi-Gigabit end-to-end services, and to meet the growing bandwidth required by the end-users. F@st 5380 benefits from the last innovations of the in-house field proven Sagemcom SWANTM software suite including big data, Wi-Fi distribution, smart diagnostics… The next generation Fiber gateways range includes two products: F@st 5688ax for 10G PON (XGS-PON
Moody’s Analytics Launches the CreditLens™ Platform23.10.2017 15:43 | Pressemelding
Moody’s Analytics has launched the CreditLens platform, our next-generation credit origination and risk monitoring solution. This new platform offers flexibility, configurability, and efficiency to lending institutions striving to establish smarter and leaner loan origination practices. The CreditLens platform reduces time-to-decision while tapping into powerful models and insightful analytics that help lenders manage risk and drive productivity. Lenders gain efficiency from the solution’s automated spreading capability and a flexible model authoring module. They also gain deep insights from built-in Moody’s Analytics Risk Grading features and Business Insights dashboards, which provide a complete view of the lender’s credit relationships. Automation in the platform also reduces errors and preserves data lineage throughout the credit assessment and origination process.
Knopp Biosciences Announces Renewal of NIH Blueprint Grant Award for Advancing KCNQ2 Modulators in Epilepsy23.10.2017 15:11 | Pressemelding
Knopp Biosciences LLC today announced the renewal and expansion of its grant award from the National Institutes of Health Blueprint Neurotherapeutics Network to advance novel treatments for epilepsy. The Phase 2 award under the NIH Small Business Innovation Research (SBIR) program anticipates NIH support of up to $2 million over the next three years of the project, subject to satisfactory completion of milestones. The renewal follows the successful completion of all milestones under a previously awarded Phase 1 grant of $400,000. Knopp is directing its potassium channel activator program to preclinical and clinical development of small-molecule drug candidates against a validated, anti-seizure pharmaceutical target encoded by the KCNQ2 gene. Knopp intends to advance novel, small-molecule KCNQ2 activators in neonatal epileptic encephalopathy, a rare disorder caused by inherit
HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 13:02 | Pressemelding
The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom