FDA Approves Nurtec™ (rimegepant): The First Oral Disintegrating CGRP Tablet for Migraine

The US Food and Drug Administration (FDA) has just approved Nurtec™ ODT (oral disintegrating tablet) for the acute treatment of migraine in adults. Nurtec (rimegepant) is the first quick-dissolving oral treatment available in the CGRP class. It may be taken once daily. Nurtec will be available to buy in early March 2020.1-2

How does Nurtec work?

A single dose of Nurtec ODT (75 mg) offers fast pain relief. Water is not required for the pill to dissolve in the mouth. Nurtec works by blocking CGRP receptors. No more than 1 dose should be taken in a 24-hour period.

What is a CGRP?

CGRP stands for calcitonin-gene-related peptide. It is a protein that acts like a neurotransmitter (a chemical messenger) in the brain and body. CGRP is found in large numbers in the nerves of the head and neck.

Researchers discovered that CGRP appears in high levels in people with migraine during an attack. A CGRP receptor, like Nurtec, blocks the protein’s ability to work, which reduces migraine symptoms.

Nurtec clinical trials

During clinical trials, more than 3,100 people were treated with Nurtec. Participants reported going from moderate to severe pain to no pain or mild pain and returned to their normal lives within 1 hour of taking Nurtec. The relief lasted up to 48 hours for many of those in the trial. Also, 86 percent of people treated with Nurtec did not need to use a migraine rescue drug such as an NSAID or acetaminophen within 24 hours.

The clinical trial did not find whether Nurtec could be taken more than 15 times over a 1 month period.

What are the side effects of Nurtec?

The most common side effect of Nurtec in clinical trials was nausea. Other side effects experienced included shortness of breath and rash, though most people had no side effects.

People with liver or kidney problems should discuss with their healthcare provider (HCP) before taking Nurtec ODT. Nurtec has not been tested in women who are pregnant or breastfeeding.

Nurtec should not be used as a preventive migraine treatment. Nurtec should not be taken if you are also taking a CYP3A4 inhibitor, CYP3A inducer, or inhibitors of P-gp or BCRP.

Nurtec is made by Biohaven Pharmaceuticals.

Read the prescribing information to learn more about Nurtec.

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