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 (QUTENZA^TM) 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 QUTENZA^TM (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.

About Astellas

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.

References:

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. QUTENZA^TM, 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

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Contact information

Astellas Pharma EMEA
Alice Cronshaw
+44 (0)7768 424046
or
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Kimberly Santiago
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