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PremiumDr Reddy’s Laboratories said on Thursday it has rolled out a wearable therapy device for drug-free management of migraine. The product named Nerivio was approved by the US Food and Drug Administration (USFDA), the Hyderabad-based drug maker said in a regulatory filing.
"Nerivio® is the first and only USFDA approved device to use Remote Electrical Neuromodulation (REN) to prevent and treat migraine," the drug maker said in a press release.
"The rollout of Nerivio marks our entry into digital therapeutics. 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," Dr Reddy’s CEO Branded Markets (India and Emerging Markets) MV Ramana said.
Here's all you need to know about Nerivio, the drug-free drug-free migraine treatment and management:
Dr Reddy’s Laboratories said Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migraine.
The drug-maker said the device is for people aged 12 years and above.
"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 headaches," it added.
Dr Reddy's said Nerivio® proved "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 nine out of 10 patients".
According to a Times of India report, Nerivio has been priced at ₹14,000-16,000.
"The device should not be used by people with uncontrolled epilepsy and those with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device," according to Theranica.
Dr Reddy’s said it entered into an exclusive agreement with Theranica in January 2023 for the marketing and distribution of Nerivio® in India. Theranica is a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions.
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The device can be worn on the upper arm. It needs to be used within 60 minutes of onset of headache for acute treatment of migraine or every alternate day for prevention of migraine, the drug maker was quoted by PTI as saying.
The device should only be applied on the upper arm over dry, healthy skin with normal physical sensation and without any metallic implants or in proximity to cancerous lesions.
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"Each device has in-built 18 x 45-minute (18 sessions of 45 minutes each) treatment sessions," Dr Reddy's said. After 18 sessions, the device has to be discarded for a fresh one. An app can be used to control the intensity levels of the device.
This user-friendly app - Nerivio app - comes with in-built features such as an interactive migraine diary 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," the drug maker said.
The app can be downloaded from Google Play Store and the Apple app store.
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Dr Reddy's explained that 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," it added.
According to the Nerivio website, the device transmits electrical pulses. The user will need to set the treatment intensity level by increasing it to the highest level that feels strong yet comfortable and painless.
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"You may feel a strong sensation at first, but it will typically fade to a comfortable level after a couple of seconds. If the sensation is uncomfortable or painful, you should decrease the intensity," it explains.
One might also experience a temporary sensation of warmth, local tingling, numbness in the arm, pain in the arm, or redness of the skin.
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