Pfizer Gets CDSCO Panel Nod to Conduct Phase IIIb Trial of Rimegepant for Menstrual Migraine
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has granted Pfizer Limited approval to conduct a Phase IIIb clinical trial of its investigational migraine treatment Rimegepant (PF-07899801).
The firm had presented the Phase IIIb clinical study protocol No. C4951063 Amendment 1 dated 05 December 2024 for review. The proposal was evaluated during the recent SEC meeting.
“After detailed deliberation, the committee recommended for grant of permission to conduct the trial as presented by the firm,” the SEC noted in its official recommendation.
The committee, however, attached a specific condition related to treatment protocol during the trial:
“The prior medications shall be allowed to the high Menstrual Migraine attack to the subject during the clinical trial.”
Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist that has received approval in multiple countries for the acute treatment and preventive management of migraine in adults. It represents a novel class of migraine therapeutics with both abortive and preventive indications.
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