Conduct post marketing clinical study to generate safety data of Nerivio: CDSCO panel Tells Dr Reddy's Lab
New Delhi: Considering the drug major Dr. Reddys Laboratorie's proposal to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct post-marketing clinical investigation in order to generate safety and performance data of the device in the Indian population.
This came after Dr.Reddy’s Laboratories presented a proposal for a grant of permission to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older.
In addition to the above the firm stated that it is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment. This device is new and there is no predicate device approved by the Central Licensing Authority.
The firm further presented the Clinical study data generated on a total of 702 patients in the USA (pilot (71 patients data) pivotal Clinical studies (631 patients data)) and post-marketing follow-up data on 14406 patients data globally.
Dr.Reddy’s Laboratories also presented the published data supporting the Clinical efficiency of the device. The firm also informed that the said device is approved in the USA and they have sold 47451 units in the US market since the year 2020.
Nerivio is the first and only FDA-cleared device to utilize Remote Electrical Neuromodulation (REN) to prevent and treat migraine. Clinical trials demonstrated that Nerivio provides consistent relief of pain and associated migraine symptoms. It is safe and well-tolerated with no systemic side effects or concern for medication overuse.
At the recent SEC meeting for Neurology and Psychiatry held on the 8th and 9th of November 2023, the expert panel reviewed the proposal for a grant of permission to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older.
Based on the presented data, the committee was satisfied with the clinical data to prove the safety and efficiency of the device and recommended consideration of the proposal.
However, the expert panel suggested that the firm should submit the protocol to conduct a Post-marketing Clinical Investigation to the Central Licensing Authority to generate safety and performance data for the device in the Indian population.
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