FDA Approves Nurtec ODT: First Oral CGRP Antagonist For Migraine Prevention and Treatment
Key takeaways:
Nurtec ODT (rimegepant) is the first orally disintegrating tablet (ODT) available in its medication class to treat and prevent migraine headaches.
The most common side effect seen with Nurtec ODT is nausea.
Nurtec ODT is currently available at pharmacies, and the manufacturer offers copay assistance programs to help make it more affordable.
Migraines — severe headaches often accompanied by nausea, vision changes, and light sensitivity — are fairly common among adults. In fact, it’s estimated that about 15% of U.S. adults have experienced a migraine or severe headache in the last 3 months.
While several different FDA-approved migraine prevention and treatment options are available, medications that affect the calcitonin gene-related peptide (CGRP) pathway have been the latest to hit the market. Earlier this year, Biohaven Pharmaceuticals announced the approval of the newest product in this category — Nurtec ODT.
Nurtec ODT is the first and only orally disintegrating tablet (ODT) available in its class and the first oral option approved for both migraine treatment and prevention. Ubrelvy (ubrogepant), an oral tablet in the same class that was approved in 2019, is only indicated for migraine treatment.
Below we will discuss how Nurtec ODT works, what side effects to expect, and when Nurtec ODT will be available.
What is Nurtec ODT?
Nurtec ODT (rimegepant) is an orally disintegrating tablet that’s FDA-approved to prevent and treat migraine headaches with or without an aura — a visual disturbance or unusual feeling that warns you of a migraine attack.
How does it work for migraine prevention and treatment?
Calcitonin gene-related peptide (CGRP) is a protein found in higher levels in the bloodstream during a migraine. Some CGRP-targeting migraine medications work by blocking the CGRP molecule itself. But as a CGRP receptor antagonist, Nurtec ODT targets its receptor (chemical binding site) and prevents CGRP from binding — blocking its downstream inflammatory effects.
How is Nurtec ODT dosed?
Nurtec ODT is available as a 75 mg orally disintegrating tablet taken by mouth. The tablet is meant to be placed on or under your tongue where it will dissolve on its own — meaning that you don’t need to take it with water. How often you take it depends on whether you’re using it for migraine prevention or treatment.
If you’re using it as an acute migraine treatment, you’ll take 1 tablet as needed for your migraine attack — but you can only take 1 tablet within a 24-hour period. And it’s unknown if using more than 18 doses in 30 days is safe.
But if you’re taking it for migraine prevention, it’s dosed more regularly. The recommended dose is 1 tablet every other day.
What are the known side effects of Nurtec ODT?
During clinical trials, Nurtec ODT was well tolerated. The most common side effect was nausea, occurring in about 2% to 3% of participants. A small percentage of participants (almost 2.5%) taking it for migraine prevention also experienced some abdominal pain or indigestion.
It’s also possible to experience an allergic reaction, including rash and shortness of breath. This can happen within several days of taking the medication. This tends to be rare, with studies showing allergic reactions in less than 1% of people taking Nurtec ODT. However, if you start experiencing signs of an allergic reaction (like shortness of breath), get medical attention right away.
These may not be all of Nurtec ODT’s potential side effects. Speak with your provider about any side effects you’re experiencing.
If you’re pregnant, planning on becoming pregnant, or nursing, speak with your provider before starting Nurtec ODT. This is because there’s not enough information available about whether the medication is safe to use during pregnancy or while nursing.
Does Nurtec ODT interact with other medications?
Yes, there are a few medications that can interact with Nurtec ODT. Below we’ll review a few notable interactions. Still, you should always check with your healthcare provider or pharmacist before starting a new medication or over-the-counter (OTC) product to make sure it’s safe.
Some medications can cause higher levels of Nurtec ODT in your body. This can be unsafe and lead to more side effects. Some combinations should be avoided, while others may restrict how soon you can take another Nurtec ODT dose. Some examples of these medications include:
Clarithromycin (Biaxin)
Diltiazem (Cardizem)
Fluconazole (Diflucan)
Grapefruit and grapefruit juice can have a similar effect and should be avoided while taking the medication.
Conversely, some medications can cause lower levels of Nurtec ODT in your body. This means that it may not work as well as intended. Some examples of these medications include:
Carbamazepine (Tegretol)
Phenytoin (Dilantin)
How does Nurtec ODT compare with other migraine medications?
Because it’s so new, there aren’t any published head-to-head studies comparing Nurtec ODT to other migraine treatments. However, let’s review some of the key differences and similarities between Nurtec ODT and other CGRP-targeting medications.
Ubrelvy
Ubrelvy (ubrogepant) — another oral CGRP receptor antagonist — was approved in December 2019 for acute migraine treatment.
One main difference between Ubrelvy and Nurtec ODT is the dosage form. While Ubrelvy is available as an oral tablet that you need to swallow, Nurtec ODT can be dissolved on or under your tongue. Because of this, it may be easier for some people to take Nurtec ODT — especially if they have difficulty swallowing tablets.
Another major difference is that Ubrelvey is only approved to treat migraine headaches — not prevent them. Nurtec ODT is approved for both migraine treatment and prevention.
Monoclonal antibodies
Monoclonal antibodies — proteins designed to target or bind to certain substances in your body — were the first CGRP-targeting medications approved for migraine prevention. They work by targeting either CGRP or its receptor, and they are only available as injections.
Examples include:
Unlike Nurtec ODT, these medications are only approved for migraine prevention — not treatment. However, Emgality can be used to treat episodic cluster headaches — severe headache attacks that can happen several times a day, sometimes lasting weeks to months.
While there are no published studies comparing Nurtec ODT to other CGRP-targeting medications, Eli Lilly and Company recently announced their plan for a head-to-head study comparing Emgality (manufactured by Eli Lilly) to Nurtec ODT for migraine prevention.
How much will Nurtec ODT cost?
Nurtec ODT is only available as a brand-name medication, so it’ll be more expensive.
A box of 8 Nurtec ODT tablets has an average retail price of around $1,000. If you have insurance coverage, your out-of-pocket cost will depend on your plan. And if you’re uninsured or if your copay is high, check with GoodRx for ways to save.
Biohaven Pharmaceuticals — the medication’s manufacturer — also offers a copay card for people with commercial insurance. If you’re eligible, you may be able to get the medication at no cost.
If you have no insurance, Biohaven also has a patient assistance program for those who qualify. Check out their website for more information.
When will Nurtec ODT be available?
The good news is that Nurtec ODT is already available. However, not all pharmacies may have it in stock, so it’s best to call ahead before you stop by to fill your prescription.
If you’re experiencing migraine headaches and are interested in giving Nurtec ODT a try, talk with your provider at your next appointment to see if it’s right for you.
The bottom line
Nurtec ODT is the first and only oral disintegrating tablet in its medication class that’s FDA-approved to treat and prevent migraine headaches. Other options that target the same pathway include an oral tablet and injections, but they are only approved for either migraine treatment or prevention — not both.
Nurtec ODT has been shown to be an effective option with mild side effects, but it can possibly interact with other medications you’re taking. Check with your healthcare provider or pharmacist before starting Nurtec ODT to make sure it’s safe.
Nurtec ODT is only available as a brand-name medication, so it may be more expensive than other options. However, the medication’s manufacturer offers a copay card and financial assistance for those who qualify to make it more affordable.
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References
Allergan, Inc. (2021). Umbrelvy [package insert].
American Migraine Foundation. (2019). Understanding cluster headache.
Biohaven Pharmaceuticals, Inc. (2020). Biohaven's Nurtec™ ODT (rimegepant) receives FDA approval for the acute treatment of migraine in adults.
Biohaven Pharmaceuticals, Inc. (2021). Nurtec ODT [package insert].
Biohaven Pharmaceuticals, Inc. (2022). Nurtec ODT.
Centers for Disease Control and Prevention. (2022). Acute migraine.
Eli Lilly and Company. (2020). Emgality [package insert].
Eli Lilly and Company. (2021). Lilly announces head-to-head study comparing once-monthly Emgality® with every-other-day Nurtec® ODT for the preventive treatment of migraine.
U.S. Food and Drug Administration. (2019). FDA approves new treatment for adults with migraine.
U.S. Food and Drug Administration. (2019). New drug class employs novel mechanism for migraine treatment and prevention.
