• Pain · Oct 2021

    Randomized Controlled Trial

    Efficacy and safety of EMA401 in peripheral neuropathic pain: results of two randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy.

    • RiceAndrew S CASCDepartment of Surgery and Cancer, Pain Research, Imperial College London, London, United Kingdom., Robert H Dworkin, Nanna B Finnerup, Nadine Attal, Praveen Anand, Roy Freeman, Alessandro Piaia, Francesca Callegari, Christie Doerr, Subhayan Mondal, Nisha Narayanan, Laurent Ecochard, Yanina Flossbach, and Shaloo Pandhi.
    • Department of Surgery and Cancer, Pain Research, Imperial College London, London, United Kingdom.
    • Pain. 2021 Oct 1; 162 (10): 257825892578-2589.

    AbstractThe analgesic efficacy and safety of 2 phase 2b studies of EMA401 (a highly selective angiotensin II type 2 receptor antagonist) in patients with postherpetic neuralgia (EMPHENE) and painful diabetic neuropathy (EMPADINE) were reported. These were multicentre, randomised, double-blind treatment studies conducted in participants with postherpetic neuralgia or type I/II diabetes mellitus with painful distal symmetrical sensorimotor neuropathy. Participants were randomised 1:1:1 to either placebo, EMA401 25 mg, or 100 mg twice daily (b.i.d) in the EMPHENE and 1:1 to placebo or EMA401 100 mg b.i.d. in the EMPADINE. The primary outcome for both the studies was change in weekly mean of the 24-hour average pain score, using a numeric rating scale from baseline to week 12. Both the studies were prematurely terminated due to preclinical hepatotoxicity on long-term dosing, although not observed in these studies. Out of the planned participants, a total of 129/360 (EMPHENE) and 137/400 (EMPADINE) participants were enrolled. The least square mean reduction in numeric rating scale pain score was numerically in favour of EMA401 100 mg arm in both EMPHENE (treatment difference: -0.5 [95% confidence interval: -1.6 to 0.6; P value: 0.35]) and EMPADINE (treatment difference: -0.6 [95% confidence interval: -1.4 to 0.1; P value: 0.10]) at the end of week 12. However, as the studies were terminated prematurely, no firm conclusion could be drawn but the consistent clinical improvement in pain intensity reduction across these 2 studies in 2 different populations is worth noting.Copyright © 2021 International Association for the Study of Pain.

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