We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Nurtec ODT
Published
Product name
Nurtec ODT
Active ingredient
Rimegepant (as sulfate)
Submission type
New Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Nurtec ODT (rimegepant (as sulfate)) was approved for the following therapeutic use:
Nurtec ODT is indicated for:
• acute treatment of migraine with or without aura in adults;
• prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month.
How this medicine works
Rimegepant binds with high affinity to the human calcitonin gene-related peptide (CGRP) receptor and antagonises CGRP receptor function.
Multiple lines of clinical evidence point to a role for CGRP in migraine pathophysiology: 1) serum levels of CGRP are elevated during migraine; 2) treatment with anti-migraine drugs returns CGRP levels to normal coincident with pain relief and 3) intravenous (IV) CGRP infusion produces lasting pain in non-migraineurs and migraineurs.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Nurtec ODT was considered favourable for the therapeutic use approved.
Sponsor