Hyderabad: Dr Reddy’s Laboratories Ltd., a global pharmaceutical company, has announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm.
The launch marks the company’s entry into digital therapeutics in Europe.
Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr. Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr. Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr. Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache.
In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent months, Dr. Reddy’s will launch Nerivio in Spain and the UK.
Last year, Dr. Reddy’s entered into an exclusive agreement with Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, for the marketing and distribution of Nerivio in multiple markets.
Migraine is a global health challenge, affecting around 30% of adults on 15 or more days per month, impacting 1.7% to 4% of the population1. The current best estimate of global migraine prevalence is 14– 15%, and, in terms of burden, migraine accounts for 4.9% of global ill health, quantified as years lived with disability. Migraines are known to have a disproportionate impact on women. Around 8 to 10 million people in Germany are affected, 14.8% of women and 6.0% of men. In India, women constitute approximately 60% of the 213 million migraine sufferers in India.
Dr. Reddy’s launched Nerivio in India in 2023. In India, Nerivio is supported by Dr. Reddy’s unique patient support programme called ‘M-Free’. The programme is a comprehensive support system that enhances and streamlines the journey of the patients. M-Free includes services such as onboarding and counseling of patients, device demonstrations, doorstep delivery, flexible payment options, informative content, and dedicated customer care to help patients get the most out of the device. With lifestyle modification as a key recommendation for better management of migraine, M-Free awareness program offers a suite of value-add services such as nutritionist consultation, yoga and meditation sessions with certified specialists for holistic medicine free migraine management.
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s said, “At a time when conversations on migraine focus on migraine as a women’s health issue, relief from migraine through the use of technology and drug-free solutions, challenges associated with managing migraine during the child-bearing age, and distinguishing migraine from headache, we are happy to take our clinically-proven first digital therapeutics product, Nerivio, to patients in our identified markets. Nerivio has had an encouraging start in India, with recommendation from neurologists in India and bringing relief to patients living with migraine. We believe this product meets a genuine unmet clinical need among migraine patients, and has the potential to reduce pill burden in migraine. We look forward to receiving patient and HCP feedback from these markets.”
The Nerivio experience has so far benefited over 45,000 patients globally. It is backed by clinical evidence from 19,000+ patients as an acute and preventive treatment option in migraine.
Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migraine with or without aura7 for adults and adolescents aged 12 years and above. Nerivio can be worn on the upper arm. Each device has in-built 18 x 45-minute treatment sessions. It is to be used within 60 minutes of onset of headache or aura for acute treatment of migraine or every alternate day for prevention of migraine. The device uses the Remote Electrical Neuromodulation (REN) mechanism to specifically activate conditioned pain modulation by stimulating nerve endings. This initiates a natural pain-relieving process in the brainstem, causing a global effect of pain inhibition that affects the original source of migraine pain in the head. The unique device is accompanied by the Nerivio app, which is user-friendly and freely available on Google Play Store and the Apple app store for download. The app can be used to control the intensity levels of the device, and to track progression through the inbuilt digital diary.
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