Need well-designed protocol with statistically validated sample size: CDSCO Panel Tells Dr. Reddy's on Nerivio
New Delhi: In line with the proposal to conduct a pivotal clinical investigation of the proposed product Nerivio, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the pharmaceutical giant Dr. Reddy's laboratories that the study should be under a scientifically robust, well-designed protocol with a statistically validated sample size.
In regards to the above, the expert panel suggested the firm submit a revised protocol for further review by the committee.
This came after the pharmaceutical giant Dr. Reddy's laboratories presented the proposal for a grant of permission to conduct a pivotal clinical investigation of the proposed product Nerivio in the country before the committee.
Nerivio is a wearable, smartphone-controlled neurostimulation device for the acute and chronic treatment of migraine. It is a smartphone-controlled wearable neuromodulation device developed by Theranica Bioelectronics, a digital therapeutics company based in Israel, for the acute treatment of episodic or chronic migraine in adolescents.
Nerivio is a safe and effective, drug-free migraine treatment and/or prevention device indicated for ages 12 and over. It is a smartphone-controlled noninvasive wearable that is discrete and easy to use.
The Nerivio device is worn on the upper arm for a 45-minute treatment and controlled via a smartphone app. During a treatment, Nerivio stimulates nerves in the upper arm through Remote Electrical Neuromodulation (REN)—nerves that carry pain signals to the brain. This action triggers a pain-management response by the brain and works with the body to naturally turn off migraine pain without medications.
At the recent SEC meeting for Neurology and Psychiatry, the expert panel reviewed the proposal presented by Dr. Reddy's laboratories for a grant of permission to conduct a pivotal clinical investigation of the proposed product Nerivio in the country before the committee.
The committee observed that the proposed study protocol is a single-arm study to be conducted on 60 patients at 5 private institutes in India.
After detailed deliberation, the committee recommended that the study should be under a scientifically robust, well-designed protocol with a statistically validated sample size.
Accordingly, the committee suggested that the firm should submit a revised protocol for further review by the committee.
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