Nurtec For Migraine 2024
May 27, 2021 was a big day for the Migraine World. For the first time, a single orally dissolvable medication, Nurtec ODT (rimegepant), was approved by the FDA for both acute and preventive Migraine therapy. Nurtec ODT is a new drug released for acute therapy in 2020 and is an CGRP antagonist that can be used with all previously FDA approved drugs for acute and preventive therapy.
There is a need for simplifying Migraine treatment and a single drug for both acute and preventive therapy would be ideal.
THIS IS BIG NEWS! NOW THERE IS 1 DRUG FOR ALL MIGRAINE!
Read my eBook on Migraine by clicking Here.
This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology, Migraine textbook author, Podcaster, YouTube video producer, and Blogger.
Nurtec ODT (rimegepant) is the only drug approved by the FDA for both acute and preventive Migraine treatment of adults. Nurtec blocks CGRP, an inflammatory neurochemical which aggravates Migraine. The Migraine process releases three neuroinflammatory chemicals—CGRP, Neurokinin A, and Substance P.
ODT means “orally dissolvable tablet.” The tablet is put in the mouth and then it dissolves. Water and a cup or glass are not needed. Drug effect onset occurs as early as 1 hour after taking Nurtec ODT.
Nurtec ODT is safe for Migraineurs with cardiovascular risk factors. Nurtec ODT is compatible with most drugs, including: CGRP preventive medication for Migraine, oral contraceptives, some antidepressants, preventive medication for Migraine, and triptans for Migraine.
For prevention treatment Nurtec ODT 75 mg is taken every other day, or up to 18 treatments per month. Previously persons with Migraine had to take an acute treatment drug, usually a triptan at the onset of their Migraine.
For Migraine attacks at a level of 3-4 or more per month, most doctors recommend starting a preventive drug. The choice here is one of the older preventive drugs used daily such as amitriptyline, topiramate, sodium valproate, or propranolol, or one of the new CGRP preventive drugs.
The CGRP drugs are given subcutaneously every 1 or 3 months. These drugs are: Aimovig, Ajovy, or Emgality. Vyepti is given by intravenous infusion. Many headache specialists are prescribing Nurtec ODT along with another CGRP medication.
Related questions.
What is Migraine?
Migraine is the 3rd most prevalent illness in the world. The World Health Organization states that migraine is one of the 10 most disabling medical illnesses. Approximately 40 million people in the U.S., and hundreds of millions worldwide, suffer from migraine.
Migraine comes with attacks lasting four to 72 hours with pulsating headaches which are often one-sided and of moderate to severe pain intensity. Migraines come with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute and preventive treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.
What kind of drug is Nurtec ODT?
Nurtec ODT (rimegepant) is a new type of Migraine medication. It is called a “gepant” class and is the second drug in this class to be approved for acute Migraine attacks. Ubrelvy (ubrogepant) was approved previously and is also a “gepant.”
How does Nurtec ODT work?
Nurtec ODT is a CGRP Receptor Antagonist. This means that the drug blocks the activity of CGRP to aggravate Migraine. Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.
Nurtec ODT targets CGRP to treat Migraine symptoms by blocking the calcitonin gene-related peptide (CGRP) receptor. CGRP is a protein found in the brain and within the trigeminal nerve.
When a Migraine attack occurs, neurons in the trigeminal nerves in the face and head become overactivated and this causes the body to release peptides like Neurokinin, substance P, and CGRP that lead to blood vessel dilation, inflammation, and pain.
Nurtec ODT works by binding to CGRP receptors like a plug (Nurtec ODT) into a socket (receptor). When CGRP is released, it cannot plug in because the socket is already full. This avoids CGRP from setting off the flow of inflammation and pain that comes with a Migraine attack.
Are there any research reports showing Nurtec ODT works for prevention?
On April 13, 2021, Biohaven Pharmaceuticals, the manufacturer of Nurtec ODT (rimegepant), announced positive results on a Phase III clinical trial of Nurtec ODT for the preventive treatment of Migraine in adults.
A press release for the company stated that the studies “showed that rimegepant demonstrated rapid onset of preventive treatment efficacy with reductions in migraine days observed within the first week of every other day dosing.”
Most previously used preventive drugs take 1-2 months to show improvement in Migraine. Nurtec ODT works in a week. In studies, 21% of participants who tried Nurtec ODT were pain-free within 2 hours.
What are the side effects of Nurtec ODT?
The side effects are said to be minimal. Nausea is the most common side effect present in 2% of patients. Serious side effects are hypersensitivity reaction to the drug, shortness of breath, and rash.
There is no “Black Box Warning.”
Who should not take Nurtec ODT?
It is restricted for persons with severe kidney or liver disease, and women during pregnancy and breastfeeding.
Nurtec ODT is not advised for children or adolescents under 18 years of age.
Read what Headache specialists say about Nurtec ODT.
Peter J. Goadsby, M.D., Ph.D., D.Sc., Professor of Neurology at the University of California, Los Angeles and King’s College London, stated:
“The FDA approval of NURTEC ODT for the preventive treatment of migraine–along with its acute treatment indication–is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine. To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine.
NURTEC ODT, with its novel quick-dissolve tablet formulation, works by blocking the CGRP receptor, treating a root cause of migraine. With this targeted mechanism of action, NURTEC ODT provides a more complete, flexible treatment plan that gives people with migraine increased control of their disease.
A single dose of NURTEC ODT can deliver fast pain relief that lasts up to 48 hours for many patients. NURTEC ODT can be taken up to once daily as needed to stop migraine attacks or taken every other day to help prevent migraine and reduce the number of monthly migraine days. This approval represents an important advancement in care for the several hundreds of millions of people living with migraine across the globe. For the first time, one medication can treat and prevent migraine attacks.”
Vlad Coric, M.D., Chief Executive Officer of Biohaven noted, "This FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks.”
“NURTEC ODT is dissolving the line between acute and preventive treatment. This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy.
At Biohaven, neuroinnovation is at the center of our focus and we are committed to finding and advancing paradigm shifting treatment options to help people with neurological diseases so they can live life without the burden of these illnesses."
The FDA approval of NURTEC ODT is based on a double-blind, randomized, placebo-controlled Phase 3 clinical trial with an open label extension. Primary study endpoint results demonstrated that NURTEC was superior to placebo, decreasing monthly migraine days by 4.3 days/month after three months of treatment.
The preventive effects of NURTEC were seen as early as the first week of therapy. Further, a key secondary endpoint result showed that approximately half of NURTEC-treated patients had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.”
Carolyn Armitage, a NURTEC preventive clinical trial participant shared, "As a middle and high school teacher, I know how important it is to show up every day for my students. I value the opportunity my career provides me to help shape young minds and lives.
But having a migraine attack almost three times a week has had a devastating impact on my professional and personal life. I was not able to be present for my students, family or friends. After trying NURTEC ODT through the clinical trial, I'm so pleased that the frequency and severity of my migraine have subsided making them more manageable."
A recent survey, Preventing Migraine Attacks: A Current Perspective by the National Headache Foundation confirms that 84 percent of people currently taking a preventive treatment wish there was a better treatment option. Among respondents, 53% wanted more migraine free days and 67% reported that their risk of anxiety and depression increases as the number of migraine attacks increase. Nearly all respondents (98%) reported they are willing to consider a new oral treatment.
Dr. Richard Lipton, headache specialist and director of the Montefiore Headache Center, explains:
“The availability of the gepants makes it possible to effectively treat patients whose needs could not be met by previously available treatments. These drugs are great news for people with Migraine and for the clinicians who treat them.”
He explains that patients who will benefit from the new drug include “people who cannot take triptans, those who do not benefit from triptans, or have cardiovascular conditions which would contraindicate the use of triptans.”
“Also, if overused, triptans may make Migraine worse by causing medication overuse headache (MOH),” said Dr. Lipton. “While the term MOH is controversial, the phenomenon that overuse of medications that relieve headache can lead to more headache is well known. Available evidence suggests that CGRP blockers prevent Migraine, giving rise to the hope that they will not cause MOH.”
Dr. Lipton explains, “Rimegepant ODT is a novel acute treatment for Migraine. It is a melt-in-your-mouth (under or on top of your tongue) tablet which shows statistically significant effects on pain relief and restoration of function at one hour after dosing.”
What is the price of Nurtec ODT?
The price of Nurtec ODT is about $850 for an 8 pack. This is similar to Ubrelvy, which is about $850 for a pack of 8 pills. A lower price could be paid depending on insurance pharmaceutical coverage.
Nurtec is a new name brand drug which is more expensive than one of the 7 triptans which have been available for 30 years and are all generic. Nurtec is priced similar to other newly approved drugs.
What is the insurance coverage for Nurtec ODT?
It is impossible to accurately answer this question because there are so many different pharmaceutical insurance plans, and they are all different. Some insurances will cover all, or part, or none at all of Nurtec ODT.
Also, many insurances require that a requesting patient fail one or two of the triptans for acute therapy of Migraine before allowing Nurtec ODT to be dispensed. This situation will improve the longer the drug is on the market.
The new medications are more expensive than triptans, which have been around long enough to have generic forms available. The price of Nurtec ODT is comparable to other newly approved treatments.
Biohaven Pharmaceuticals has a Patient Savings Program for eligible patients with commercial insurance.
Biohaven is committed to supporting the migraine community by eliminating barriers to medication access. The company plans to continue the $0 co-pay card in which eligible people will pay as little as $0. For eligibility requirements and to enroll in the patient support program, please call 1-833-4-NURTEC or visit www.NURTEC.com.
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All the best.
Britt Talley Daniel MD
