Last Updated on December 31, 2023 by The Health Master
Migraine
In a groundbreaking move, the Subject Expert Committee (SEC), responsible for advising the national drug regulator, has given its nod to Dr. Reddy’s Laboratories‘ proposal for the import of Nerivio.
This wearable migraine treatment, developed in collaboration with Israel-based Theranica, marks a significant advancement in the realm of migraine care.
Understanding Nerivio: A Prescription Wearable
Nerivio, the nerve electrical stimulator, is designed for both acute and preventive treatment of migraines in patients aged 12 and older.
It’s a self-administered device intended for home use, providing relief at the onset of a migraine or as a preventive measure every other day.
The Committee for Neurology and Psychiatry, in a recent meeting, highlighted its novelty, emphasizing the absence of a similar approved device by the Central Licensing Authority.
Backing Data: Clinical Studies and Global Impact
The SEC’s decision was based on comprehensive data, including clinical studies conducted on 702 patients in the USA and post-marketing follow-up data from 14,406 patients globally.
Dr. Reddy’s Laboratories presented a compelling case, citing the device’s approval in the USA and substantial sales figures, with 47,451 units sold since 2020.
Safety and Efficiency Validation
The Committee expressed satisfaction with the presented data, affirming the safety and efficiency of Nerivio.
This FDA-cleared, digitally connected, drug-free wearable has demonstrated its prowess in acute treatment for both episodic and chronic migraines.
Unique Mechanism: Remote Electrical Neuromodulation (REN)
Worn on the upper arm, Nerivio employs remote electrical neuromodulation (REN) to trigger conditioned pain modulation (CPM), an endogenous pain inhibition mechanism.
Clinical studies attest to its efficacy, placing it on par with traditional pharmacological options for acute migraine treatment.
Strategic Partnership: Theranica and Dr. Reddy’s Laboratories
The approval in India is a result of a strategic license and supply agreement announced earlier this year.
Theranica and Dr. Reddy’s Laboratories collaborated for the exclusive marketing and distribution of Nerivio in India, subject to regulatory approval. Recently, this partnership expanded to include several European countries, solidifying Nerivio’s global presence.
Future Steps: Post-Marketing Clinical Investigation
While the SEC recommends the proposal, Dr. Reddy’s Laboratories is obligated to submit a post-marketing clinical investigation protocol to generate safety and performance data specific to the Indian population.
This step underlines a commitment to ongoing evaluation and improvement.
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