Rimegepant Approved by FDA for the Acute Treatment of Migraine in Adults

CGRP receptor antagonist available as fast-acting orally disintegrating tablet

On February 27, 2020, the FDA approved rimegepant (NURTEC™) for the acute treatment of migraine in adults. This is the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).

Rimegepant works by blocking CGRP receptors which offers an alternative treatment for those who experience inadequate efficacy, poor tolerability or have a contraindication to current acute therapies. Rimegepant is not an opioid and does not have addiction potential.

Clinical Trials

The FDA approved rimegepant based on results from the Phase 3 clinical trial (Study 303) and the long-term, open-label safety study (Study 201).

In the Phase 3 clinical trial (Study 303), patients who received rimegepant achieved pain freedom and freedom from the most bothersome symptom at two hours post-dose compared to the placebo group. These benefits were seen with a single dose of rimegepant and were sustained up to 48 hours post-dose for many patients. Eighty-six percent of patients treated with rimegepant did not require rescue medication, such as NSAIDS or acetaminophen, within 24 hours after taking the medication.

The long-term open-label study (Study 201) assessed the safety and tolerability of rimegepant with multiple doses used up to one year. The study evaluated 1,798 patients who used 75 mg of rimegepant to treat migraine attacks as needed, up to one dose per day. All the participants treated an average of at least two migraine attacks per month. The safety of treating more than 15 migraine attacks in a 30-day period has not been established.

Side Effects and Contraindications

The most common adverse reaction reported during the Phase 3 clinical trial was nausea, occurring in 2% of patients who received the treatment compared to 0.4% of patients who received the placebo. Dyspnea and severe rash, including delayed serious hypersensitivity days after taking the medication, occurred in less than 1% of patients taking rimegepant in clinical studies. Rimegepant is contraindicated in patients with hypersensitivity to rimegepant.

For more information on rimegepant that can be used to inform treatment decisions, refer to the prescribing information.

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