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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

DateArticle
May 27, 2021Approval  FDA Approves Biohaven's Nurtec ODT (rimegepant) for Preventative Treatment of Migraine
Feb 27, 2020Approval  FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine in Adults
Jul  1, 2019Biohaven Enrolls First Patient in Phase 2 Clinical Trial of Rimegepant, Oral CGRP Receptor Antagonist, for Treatment Refractory Trigeminal Neuralgia
Mar 13, 2019Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant
Dec 10, 2018Biohaven Announces Positive Results from Ongoing Rimegepant Long-Term Safety Study
Mar  6, 2018Biohaven Enrolls First Patient In Phase 3 Clinical Trial To Evaluate Rimegepant Zydis┬« ODT In The Acute Treatment Of Migraine
Nov 27, 2017Biohaven Completes Enrollment in Second Pivotal Phase 3 Clinical Trial of Oral CGRP-Receptor Antagonist Rimegepant
Jul 24, 2017Biohaven Enrolls First Patient In Pivotal Phase 3 Clinical Trial of Oral Rimegepant for the Acute Treatment of Migraine

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.