- The approval is based on the P-III OLE trial involves assessing Nurtec ODT (rimegepant, 75 mg) vs PBO in patients with episodic migraine who experience less than 15 headache days/mos.
- The 1EPs & 2EPs of the trial demonstrate a reduction in monthly migraine days by 4.3 days/mos. after 3mos. treatment, 50% patients reported at least >50% reduction in moderate-to-severe migraine days /mos., 95% of all US migraine patients experience less than 15 headache days/ mos.
- Nurtec ODT (rimegepant) is the first and only CGRP receptor antagonist approved by the FDA for migraine as a dual therapy for both the acute and preventive treatment
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