Dr.Reddy’s rolls out Nerivio® in Indian market

Dr. Reddy’s Laboratories, a global pharmaceutical company, on Thursday announced the roll-out of Nerivio®, a state-of-the-art United States Food and Drug Administration (USFDA) approved wearable therapy device for drug-free management of migraine. The roll-out of Nerivio in the Indian Market, marks Dr Reddy entry into digital therapeutics (DTx). 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, Hyderabad-based pharma giant said in a release. 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 is the first and only USFDA approved, 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).

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, non-invasive, 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, he added. 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, the release said. 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 a long time ( >3 months), the release added. In January 2023, 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 India. In August this year, Nerivio® received an expanded CE mark approval under MDR European regulation as a dual-use (acute and/or prevention) migraine treatment for adults and adolescents. Dr. Reddy’s also recently signed an exclusive agreement for the commercial marketing and distribution of Nerivio® in Germany, Austria, Czech Republic, Denmark, Finland, France, Italy, Norway, Poland, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Nerivio® is a prescription-based product. Patients are advised to consult their neurologists on the use of the device and management of migraine.