Peripheral Neuropathic Pain Patients in Sweden set to Benefit From First-of-a-Kind Treatment Which Provides Lasting Pain Relief

STAINES, England, February 28, 2011 /PRNewswire/ --

- Decision to Reimburse Qutenza(TM) (capsaicin 8% w/w dermal patch) by Sweden's Dental and Pharmaceutical Benefits Agency (Tand-och Lakemedelsformansverket) Gives new Option to Patients Living With Difficult-to-Treat Condition

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.[1],[2] 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.[3] 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.[4],[5]

"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 of treatment."

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.[6],[7] Pain relief is rapid in onset (between one and two weeks to take full 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 greater than or equal to 30% decrease in pain compared with 33% of controls.[6] In the same study, twelve weeks post-treatment, 55% of patients treated with capsaicin 8% w/w still reported improvement in pain relief compared to 43% of controls.[6] The reported side effects with the high concentration capsaicin patch are temporary, self-limiting and mild to moderate in intensity.[6],[7],[8]

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 dosing.[6] Since the capsaicin 8% w/w dermal patch acts only on the affected area, with a minimal amount of capsaicin being absorbed into the body,[8] application 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.[6]

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 the coming months.

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 pain.[8] When 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 months.[8] After three months the treatment can be re-applied, if required.[8]

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 neuropathic pain.

About Astellas 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 these regions.

References

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[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: http://bit.ly/evoQhp Last accessed: 24th February 2011

[3] Läkemedelsverket. Bakgrundsdokumentation. Farmakologisk behandling av neuropatisk smerta. Epidemiologi. Information från Läkemedelsverket 6: 2007(2) available at: http://bit.ly/g1y5km 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: http://bit.ly/hK6WTk Last accessed: 24th February 2011