Dr Reddy's Labs unveils USFDA-approved drug-free non-invasive migraine management device Nerivio in India

Hyderabad: Dr Reddy’s Laboratories Ltd., a global pharmaceutical company, has announced the roll-out of Nerivio in India, a state-of-the-art United States Food and Drug Administration (USFDA) approved wearable therapy device for drug-free management of migraine.

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 population. Migraines are known to have a disproportionate impact on women, who constitute approximately 60% of the 213 million migraine sufferers in India alone.

Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migraine with or without aura 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 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.

M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s said, “The roll-out of Nerivio marks our entry into digital therapeutics (DTx). It is an area that is seeing increasing adoption by physicians as well as patients due to its potential to reduce pill burden and decrease dependency on non-specific medication in chronic or hard-to-treat diseases. Given the migraine disease burden, its associated symptoms, lack of effective treatment and impact on well-being, quality of life and productivity, we are happy to bring Nerivio to India. It is USFDA-approved, drug-free, noninvasive, first-of-its-kind product for migraine in India and offers a favourable safety profile. We believe this product meets a genuine unmet clinical need among migraine patients. We look forward to receiving patient and HCP feedback on it. While our core generics business continues to drive our current growth, Nerivio as DTx joins our e-commerce venture ‘Celevida Wellness’, and our recent deals to bring novel molecules such as toripalimab and pyrotinib to India, as part of our innovative products initiatives in India aimed at improving patient well-being and outcomes.”

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. It also has an interactive migraine diary which can be used to log symptoms, track responses and share insightful analytics. The app also includes an interactive GIER (guided, imagery, education and relaxation) protocol which, if used with Nerivio, significantly increases the response rates. As part of its patient support programme for Nerivio, Dr. Reddy’s offers M-Free, 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. Clinically proven and safe, Nerivio is suitable for a wide range of patients, including those who prefer drug-free options, individuals with contraindications to medications or poor medication tolerance, sensitive populations such as adolescents, women of vulnerable age groups and patients at risk of medication overuse headache.

Studies show that Nerivio is safe and well tolerated with no systemic side effects or concern for medication overuse. It has been evaluated in robustly designed pivotal studies conducted in the U.S., in patients seeking effective acute or preventive treatment of migraine. Nerivio has proven efficacy in not only effectively treating relief of pain but also associated symptoms in migraine such as nausea, vomiting etc. It has been shown to reduce the need for drugs used for acute treatment in nearly 9 out of 10 patients. Being an effective non-invasive therapy, the associated systemic adverse events are not a concern. This is extremely useful in patients seeking preventive treatment of migraine since many patients experience tolerability issues with drugs, resulting in significant impact on their quality of life, when used for long time (>3 months).