Augsburg – 08. November 2023
Remote Electrical Neuromodulation (REN) – the new drug-free therapy option for migraines will also be available in Germany from 2024
With Remote Electrical Neuromodulation (REN), a new drug-free therapy option for the acute treatment and prevention of episodic and chronic migraines will be available in Germany from spring 2024. The results of clinical studies on the effectiveness and tolerability of the new method were presented to the specialist public for the first time in the run-up to the congress of the German Society for Neurology (DGN). “REN is a promising treatment option as a supplement or alternative to standard therapy, especially for patients for whom drug treatment is contraindicated or if those affected have a preference for non-pharmacological treatment,” explained PD Dr. med. Charly Gaul, neurologist and pain therapist at the Headache Center in Frankfurt.
Press kit for the REN trade press conference on November 7, 2023 for download
Migraine is considered the most common neurological disease – with great distress for those affected 1. Migraine is the most common cause of disability in adolescents and adults worldwide 2. “Prophylactic pharmacotherapy can only reduce the frequency of headaches by over 50 in around half of migraine patients % to reduce. During an acute attack, only a maximum of 60% of patients achieve pain relief within two hours. “There is therefore a need for further therapy options,” emphasized Prof. Stefan Evers, headache expert and chief physician at the Department of Neurology at the Lindenbrunn Hospital in Coppenbrügge.
Suitable for migraine patients aged 12 and over
Remote Electrical Neuromodulation (REN) can be used both to reduce the pain of an acute migraine attack and preventively to reduce migraine days in episodic and chronic migraines from the age of 12. REN activates the body’s own pain control mechanisms (Conditioned Pain Modulation, CPM) through subjectively painless electrical impulses on the upper arm, which leads to relief from migraine headaches or freedom from pain 3. The prescription neuromodulation bracelet for migraine therapy is controlled via an app and worn on the upper arm . The self-treatment lasts 45 minutes and is carried out acutely when a migraine attack begins or as a preventive measure every other day.
Study program proves effectiveness and tolerability
The effectiveness, tolerability and effectiveness of non-invasive neuromodulation using the REN method have been evaluated in an extensive study program since 2017. As the prospective, double-blind, randomized and placebo-controlled studies show, REN is suitable for patients with episodic or chronic migraine 3–6. The method also proved to be effective both in acute treatment and in migraine prophylaxis 7. The use of REN reduced the pain intensity of migraines in those affected or led to complete freedom from pain. In some cases, patients also reported fewer side effects such as nausea, sensitivity to light or noise 5, 6. What should be emphasized is the good tolerability that was observed across all studies. REN is also effective in adolescents, as shown by a prospective, open, multicenter study 8.
“Compared to placebo, REN leads to clinically significant relief of migraine pain and the associated, most distressing accompanying symptoms and is therefore a well-tolerated and effective non-pharmacological alternative for acute migraine treatment,” concludes Prof. David Yarnitsky, Director of Neurology at Rambam Hospital, Israel, and author of several studies.
The prescription migraine therapy device Nerivio® has been approved by the Food and Drug Administration (FDA) in the USA since 2019. It has had CE marking for the European market since 2020. The market launch in Germany is planned for spring 2024.
literature
1 Porst M et al. Migraines and tension headaches in Germany. Prevalence and disease severity in the BURDEN 2020 disease burden study. Journal of Health Monitoring 5(S6):2-26
2 Leonardi M et al. Global Burden of Headache Disorders in Children and Adolescents 2007–2017. Int J Environ Res Public Health. 2020 Dec 31;18(1):250.
3 Yarnitsky D et al. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache 2019; 59:1240-1252
4 Yarnitsky D et al. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology 2017; 88(13):1250-1255
5 Nierenburg H et al. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther 2020; 9:531-543
6 Grosberg B et al. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021; 6(4):e966
7 Tepper SJ et al. Remote electrical neuromodulation for migraine prevention: A double-blind, randomized, placebo-controlled clinical trial. Headache 2023; 63(3):377-389
8 Hershey AD et al. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache 2021; 61(2):310-317
Press contact: Tel. +49 (0) 89 461486 – 11, [email protected]
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Further information and press releases on the study situation, active principle and suitability for different patient groups can be found in the press kit for the specialist press conference on November 7th, 2023.
Also visit the betapharm symposium “Positive vibrations in migraine therapy through non-invasive neuromodulation” on Friday, November 10th, 2023, 4:30 p.m. – 6 p.m., room M 6-7, at the congress of the German Society for Neurology (DGN) in the CityCube Berlin. Participation is possible on site and online. Please accredit yourself free of charge as a journalist for the DGN Congress 2023.
Betapharm Arzneimittel GmbH is a pharmaceutical company that was founded in Augsburg in 1993 and is one of the leading generic drug manufacturers in Germany. With around 120 active ingredients in over 900 commercial forms, the focus of prescription medicines is on neurology/psychiatry, pain, HIV and oncology; the OTC range covers numerous indications. Since 2006, betapharm has been part of the international pharmaceutical group Dr. Reddy’s Laboratories. www.betapharm.de
Nerivius® is a non-invasive neuromodulation device for the acute and preventive treatment of episodic and chronic migraines with or without aura. The innovative drug-free therapy option is suitable for adults and adolescents aged 12 and over. The method, known as Remote Electrical Neuromodulation (REN), activates the body’s own pain control mechanisms (Conditioned Pain Modulation, CPM) through subjectively painless electrical impulses. The prescription neuromodulation bracelet is worn on the upper arm and controlled via a smartphone app. Nerivio® was developed in Israel by Theranica Bio-Electronics, a leading digital therapeutics company. Nerivio® has been approved by the Food and Drug Administration (FDA) in the USA since 2019. Since 2020, Nerivio® has had a CE marking for the EU. In spring 2024, betapharm will bring Nerivio® onto the German market. www.nerivio.de