Peripheral neuropathic pain patients in Sweden set to benefit from first of a kind treatment which provides lasting pain relief Decision to reimburse QUTENZATM (capsaicin 8% w/w dermal patch) by Sweden’s Dental and Pharmaceutical Benefits Agency (Tand-och Läkemedelsförmånsverket) gives new option to patients living with difficult-to-treat condition
Staines, UK, 28th February 2011 – Patients in Sweden living with peripheral neuropathic pain are set
to gain access to a new treatment option which can provide pain relief for up to three months
following a single 30- or 60-minute application. The new treatment patch uses capsaicin – the
substance found in chilli peppers which gives them their ‘heat’ – to change the function of pain
sensing nerves in the area of skin affected.,The Dental and Pharmaceutical Benefits Agency (TLV)
has confirmed that the capsaicin 8% w/w dermal patch will be reimbursed for patients who have not
tolerated, or who have not achieved adequate pain relief from, amitriptyline or gabapentin.
Neuropathic pain is caused by damage to nerves and it is estimated that approximately 1.5% of the
Swedish population may require treatment for the condition.It is a complex and difficult-to-treat
disorder that can last indefinitely and have a detrimental effect on a patient’s quality of life.,
“In many patients peripheral neuropathic pain substantially affects quality of life aspects. With currently used evidence based pharmacological treatments, frequently with bothersome side effects, we are able to relieve pain in a useful way in 30-40% of patients only. Hence there is a huge need for new effective treatments that are minimally side effect prone and that do not interact with other medicines. With Qutenza we can treat selected patients with peripheral neuropathic pain in the area where pain is experienced,” says Per Hansson, professor and senior consultant at the Pain
Center, Karolinska University Hospital in Stockholm. “It is now pertinent to accumulate and communicate treatment related experience on which types of pain are most susceptible to this type
The efficacy and safety of the capsaicin 8% w/w dermal patch have been investigated in a
comprehensive clinical trial programme involving 1,327 patients who received at least one
application. The treatment has been shown to significantly reduce neuropathic pain. Pain relief is
rapid in onset (between one and two weeks to take ful effect) and long-lasting following a single
application. Reductions in pain were achieved with high concentration capsaicin treatment when
used alone or in combination with other treatments for pain. In clinical trials, 44% of patients with
post-herpetic neuralgia, a type of peripheral neuropathic pain, treated with the patch reported ≥ 30% decrease in pain compared with 33% of controls
treatment, 55% of patients treated with capsaicin 8% w/w still reported improvement in pain relief compared to 43% of controlsThe reported side effects with the high concentration capsaicin patch are temporary, self-limiting and mild to moderate in intensity
February 2011
Use of conventional therapies for peripheral neuropathic pain can be restricted by factors such as
side effects, drug-drug interactions, slow onset of action, the need for potentially complex titration
and multiple daily dosinince the capsaicin 8% w/w dermal patch acts only on the affected area, with a minimal amount of capsaicin being absorbed into the bodyapplication of the patch is not
associated with systemic drug-drug interactions or side effects such as sedation and dizziness that may be experienced with other treatments currently prescribed for neuropathic pain
The capsaicin 8% w/w dermal patch has to be applied by a healthcare professional. It is already
available in a number of European countries and will become more widely available across Europe in
Notes to editors
About the TLV
The Dental and Pharmaceutical Benefits Agency, TLV, is a central government agency whose remit is
to determine whether a pharmaceutical product or dental care procedure shall be subsidised by the
Swedish state and also to monitor profitability on the reformed pharmacy market.
About the capsaicin 8% w/w dermal patch
The capsaicin 8% w/w dermal patch is approved by the European Medicines Agency for the
treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for painWhen applied to the painful area of skin for 30 or 60 minutes and then removed, the patch can provide relief from the pain for up to three monthsAfter three months the treatment can be re-applied, if required
The patch delivers a high-dose of a synthetic form of capsaicin (the substance found in chilli peppers
which gives them their ‘heat’) directly to the hyperactive 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 treatment is released quickly which overstimulates the pain sensing nerves in the
skin. Overstimulating the pain sensing nerves makes them become “defunctionalised”, effectively
making them unresponsive to stimuli that normally cause pain for patients with peripheral
About Astel as Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary 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 pharmaceutical products. The
organisation is committed to becoming a global company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma
Europe Ltd. is responsible for 20 affiliate offices located across Europe, the Middle East and Africa,
an R&D site and three manufacturing plants. The company employs approximately 3,400 staff across
February 2011 References
1 Knotkova H, et al. Capsaicin (TRPV1 agonist) therapy for pain relief: Farewell or Revival? Clin J Pain 2008;24 (2):142–154
2 QUTENZA (capsaicin) EPAR summary for the public. Available from: Last accessed: 24th February 2011
3 Läkemedelsverket. Bakgrundsdokumentation. Farmakologisk behandling av neuropatisk smerta. Epidemiologi. Information från Läkemedelsverket 6: 2007(2) available at: Last accessed: 24th February 2011
4 Gálvez R et al. Cross-sectional evaluation of patient functioning and health-related quality of life in patients with neuropathic pain under standard care conditions. European Journal of Pain 2007;3:244– 55
5 Smith B et al. Health and Quality of Life Associated With Chronic Pain of Predominantly Neuropathic Origin in the Community. Clinical Journal of Pain 2007;23:143–9
6 Backonja, M et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurology 2008;7(12):1106–12
7 Simpson DM, et al. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology 2008;70(24):2305–13
8 QUTENZA Summary of Product Characteristics. Available from: Last accessed: 24th February 2011 For further information please contact:
PROCESS RESOURCES, INC. PRI 10440 CORPORATE DRIVE • SUGAR LAND, TEXAS 77478 281-240-0955 • FAX 281-240-8025 e-mail: richardtrout@processresources.com PROCESS RESOURCES, INC. AND SUBSIDIARIES STANDARD TERMS AND CONDITIONS OF SALE The equipment, software, materials and services (collectively, the “Equipment”) which are described on the face hereof shall
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Peripheral neuropathic pain patients in Sweden set to benefit from 
Use of conventional therapies for peripheral neuropathic pain can be restricted by factors such as
side effects, drug-drug interactions, slow onset of action, the need for potentially complex titration
and multiple daily dosinince the capsaicin 8% w/w dermal patch acts only on the affected area, with a minimal amount of capsaicin being absorbed into the bodyapplication of the patch is not
associated with systemic drug-drug interactions or side effects such as sedation and dizziness that may be experienced with other treatments currently prescribed for neuropathic pain
The capsaicin 8% w/w dermal patch has to be applied by a healthcare professional. It is already
available in a number of European countries and will become more widely available across Europe in
