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
19.11.2015 14:00 | Business Wire
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
The Valence Group Issues Fairness Opinion to SK Capital in Connection with Archroma18.8.2017 13:30 | Pressemelding
The Valence Group has provided a fairness opinion to SK Capital Partners, LP in connection with its recapitalization of Archroma, including investments made by various affiliates of SK Capital. Terms of the transaction were not disclosed. About SK Capital SK Capital is a private investment firm focused on the specialty materials, chemicals and pharmaceutical sectors. The firm builds strong and growing businesses that generate substantial long-term value for its investors. SK Capital utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing companies with improved strategic positioning, growth, profitability and risk profiles. The firm currently has approximately $1.9 billion of assets under management and its portfolio companies generate revenues of over $5.0 billion annually and employ approximat
Biker Summer 2017 campaign: What’s happening during Biker Summer 2017? Moto-tyres.co.uk is giving away exciting prizes!18.8.2017 09:22 | Pressemelding
Whether it’s a short weekend break or a long-distance tour – once again this year Moto-tyres.co.uk is asking bikers from 10 countries about their dream destinations and longest journeys as part of its “Biker Summer 2017” campaign. To ensure than nothing gets in the way of your next tour, the two-wheeler tyre store from Delticom, Europe’s leading online tyre dealer, is entering anyone who completes the survey before 30 September 2017 into a prize draw to win some great biking accessories. Simply answer three short questions about your plans for bike tours this year (don’t forget to provide your name and email address), and with a bit of luck, you might win one of these great prizes. Up for grabs are a GARMIN motorbike GPS system, a GoPro camera with helmet bracket and five 200-Pound vouchers for new motorbike tyres from the online store – thanks to the product range at Moto-tyres.co.uk, eve
Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 00:04 | Pressemelding
Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We
Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57 | Pressemelding
Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08 | Pressemelding
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 07:00 | Pressemelding
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom