Dr. Reddy's said it is rolling out Nerivio, a USFDA-approved drug-free non-invasive migraine management device, in India.
Nerivio is a drug-free wearable and intended for acute and prophylactic (preventive) migraine in patients aged 12 years and above, the company said in a press statement on November 16. The device is prescription-based and non-invasive.
Migraines affect 30 percent of adults globally with a notable impact on women, constituting 60 percent of the affected in India.
“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,” said MV Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr Reddy’s.
Positioned as a digital therapeutic (DTx), Nerivio seeks to reduce pill dependency and enhance disease management. Worn on the upper arm, each device offers 18 sessions for acute treatment. Employing Remote Electrical Neuromodulation (REN), it activates pain modulation, providing natural relief in the brainstem. It is to be used within 60 minutes of the onset of headache for acute treatment of migraine or every alternate day for prevention of migraine.
The device is accompanied by the Nerivio app, which is available fro free on the Google Play Store and the Apple App Store and can be used to track the symptoms, responses and provide analysis.
Nerivio is suitable for people, 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.
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 US 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. This is extremely useful in patients seeking preventive treatment of migraine since many patients experience tolerability issues with drugs, resulting in a significant impact on their quality of life, when used for a long time (>3 months).
Dr Reddy's partnered with Theranica, a digital therapeutics company, for Nerivio's marketing and distribution in India. The device received an expanded CE mark approval for dual use in Europe. The agreement also extends Nerivio's reach to several European countries.
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