Nurtec ODT FDA Approval History
Last updated by Judith Stewart, BPharm on June 1, 2021.
FDA Approved: Yes (First approved February 27, 2020)
Brand name: Nurtec ODT
Generic name: rimegepant
Dosage form: Orally Disintegrating Tablets (ODT)
Company: Biohaven Pharmaceutical Holding Company Ltd.
Treatment for: Migraine; Migraine Prophylaxis
Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine with or without aura, and the preventive treatment of episodic migraine, in adults.
- Nurtec ODT is an orally disintegrating tablet formulation intended to be dissolved on or under the tongue without the need for water or other drink. The orally disintegrating tablets must be stored in the blister pack they are supplied in until required for immediate use.
- Acute treatment of migraine: The recommended dosage is one 75 mg orally disintegrating tablet to be taken as needed. The maximum dose in a 24-hour period is 75 mg. It is not known if it is safe to take more than 18 doses in 30 days.
- Preventive treatment of episodic migraine: Recommended dosage is one 75 mg orally disintegrating tablet to be taken every other day. The maximum dose in a 24-hour period is 75 mg.
- Nurtec ODT may cause serious hypersensitivity reactions that can happen days after taking a dose. Patients should receive emergency medical help if they experience signs of an allergic reaction such as swelling of the face, mouth, tongue, or throat, or trouble breathing.
- The most common side effect of Nurtec ODT when used for the acute treatment of migraine is nausea. The most common side effects when used for preventive treatment are nausea and abdominal pain/dyspepsia.
Development Timeline for Nurtec ODT
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