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Astellas Granted Label Extension for QUTENZA[TM] (capsaicin 8% patch) to Include Treatment of Diabetic Patients With Peripheral Neuropathic Pain (PNP)
Chertsey, England (ots/PRNewswire) - Astellas Pharma Europe Ltd. today announced the European Commission has granted approval for a label extension for QUTENZA[TM] (capsaicin 8% patch) to include the treatment of adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain. The capsaicin 8% patch was first granted marketing authorisation by the European Commission in May 2009 with a licence that excluded adult patients with diabetes.,
"This is significant for those suffering with the debilitating effects of painful diabetic peripheral neuropathy (pDPN) as they now have a new treatment option. This decision reinforces the efficacy and tolerability of the capsaicin 8% patch in a wide range of patients, as well as the commitment of Astellas to help patients with this difficult-to-treat condition," commented Kay Drake, Senior Vice President Marketing, Astellas Pharma EMEA.
The European Commission decision follows the positive opinion from the Committee for Medicinal Products for Human Use provided in July 2015. The approval is based on outcomes of two clinical trials examining the efficacy and safety of the capsaicin 8% patch in patients with pDPN.,
pDPN is a debilitating condition that may affect one in four patients with type 2 diabetes. The capsaicin 8% patch acts by directly targeting the source of neuropathic pain. In non-diabetic patients it has demonstrated rapid, targeted pain relief directly to the area of pain giving patients significant pain relief for up to three months following a single application., Outcomes of clinical studies found the capsaicin 8% patch provided statistically significant improvements in pain relief and sleep quality in patients with pDPN, with no new safety issues associated with a single treatment or repeated treatment over 52 weeks.,
Notes to Editors
About neuropathic pain
Neuropathic pain, a type of pain caused by a lesion or disease of the somatosensory nervous system, is a well-characterised neurological condition, which has been estimated to affect approximately 7-8% of the general population in Europe., The pain intensity varies and can impact a person's quality of life, general health and social and economic well-being.
About QUTENZA(TM) (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. 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. As a result of treatment-related discomfort, transient increases in blood pressure may occur during and shortly after treatment with the capsaicin 8% patch. There have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches.
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. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). CHMP post-authorisation summary of positive opinion for Qutenza http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000909/smops/P ositive/human_smop_000852.jsp&mid=WC0b01ac058001d127 (accessed September 2015)
2. 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 September 2015).
3. QUTENZATM, Summary of Product Characteristics. Available from: http://www.medicines.org.uk/emc/medicine/23156 (accessed September 2015).
4. Stoker M, et al. Double-blind, randomised, placebo-controlled study of the efficacy and safety of capsaicin 8% patch (QUTENZATM) in patients with painful diabetic peripheral neuropathy: STEP Study. Presented at 5th International Congress on Neuropathic Pain (NeuPSIG), Nice, France, May 2015. Data on File. Astellas Pharma Europe Ltd. DOF QTZ/15/0015/EU.
5. Vinik I, et al. Long-term safety and efficacy of repeated applications of capsaicin 8% patch (QUTENZATM) in painful diabetic peripheral neuropathy: PACE Study. Presented at 24th American Association of Clinical Endocrinologists (AACE). Nashville, Tennessee, May 2015. Data on File. Astellas Pharma Europe Ltd. DOF QTZ/15/0011/EU.
6. Davies M, et al. The Prevalence, Severity, and Impact of Painful Diabetic Peripheral Neuropathy in Type 2 Diabetes. Diabetes Care, 2006;20(7):1518-22.
7. 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.
8. Simpson DM, et al. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology 2008;70(24):2305-13.
9. Jensen, Troels S, et al. A new definition of neuropathic pain. Pain 2011;152(10) :2204-5.
10. 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.
11. Bouhassira D, et al. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain 2008;136:380-387.
12. NICE clinical guidelines 173 Neuropathic Pain - pharmacological management. November 2013. Available from: https://www.nice.org.uk/guidance/cg173/resources/guidance-neuropathic-pain-pharmacological -management-pdf (accessed September 2015).
13. 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.
Astellas Contacts: Alice Cronshaw, Astellas Pharma EMEA,
+44(0)7768-424046; Georgina Eaton, Red Door Unlimited,