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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FAQs
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).
Is rimegepant approved for migraine prevention? ›
Rimegepant is generally well tolerated. As the first medication approved to both treat acute migraine attacks and help prevent future attacks, rimegepant represents a useful treatment option for patients with migraine.
What is the FDA approved treatment for cluster headaches? ›
Emgality 300 mg can help give you more cluster headache-free moments to celebrate. It's the first and only medication approved by the FDA to reduce the number of attacks. Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality.
Is Nurtec approved for cluster headaches? ›
Is Nurtec ODT used to treat cluster headaches? No, Nurtec ODT isn't approved to treat cluster headaches. It's only approved for prevention of migraine symptoms due to episodic migraine and acute (immediate) treatment of migraine episodes with or without an aura.
What are the FDA approved CGRP antagonists? ›
Zavegepant (Zavzpret) is a novel FDA-approved CGRP receptor antagonist. Clinical trials have demonstrated its efficacy in providing headache and symptom relief. It has mild adverse effects, such as taste disorders and nausea.
When was rimegepant FDA approved? ›
On February 27, 2020, the FDA approved rimegepant (NURTEC™) for the acute treatment of migraine in adults.
What is the success rate of rimegepant? ›
Treatment with 75 mg rimegepant showed significant efficacy compared to the placebo with respect to all of the primary outcomes (freedom from pain 2 hr post dose, 20.6% vs 12.5% for rimegepant vs placebo RR = 1.70, 95% CI:1.39–2.08, P < 0.001; freedom from most bothersome symptoms, 36.0% vs 25.1% for rimegepant vs ...
What is the drug of choice for migraines and cluster headaches? ›
The calcium channel blocking agent verapamil (Calan SR, Verelan) is often the first choice for preventing cluster headache. Verapamil might be used with other medicines. Sometimes, longer term use is needed to manage chronic cluster headache. Most people can take verapamil without problems.
What is the first line of medication for cluster headaches? ›
Subcutaneous sumatriptan and high-flow oxygen are the most proven abortive treatments for cluster headache attacks, but other treatment options such as intranasal triptans may be effective. Verapamil and lithium are the preventive drugs of first choice and the most widely used in first-line preventive treatment.
Is there a permanent cure for cluster headache? ›
Unfortunately, there is no cure for cluster headaches. But you do have treatment options that can make them a little less painful or less frequent. Your healthcare provider will work with you to develop an appropriate treatment plan.
Side Effects
- Acid or sour stomach.
- belching.
- heartburn.
- indigestion.
- nausea.
- stomach discomfort, upset, or pain.
As an acute treatment to treat the migraines that you do get: around six out of ten people will feel pain relief within two hours. nearly nine out of ten people will not need to take any more pain killers in the next 24 hours.
Why is Nurtec so expensive? ›
Why is Nurtec so expensive? Several factors contribute to the high price point of Nurtec, such as the “cost of inventing, testing, researching, and manufacturing the medication,” Gross says. In addition, there are currently no generic alternatives to Nurtec.
What is the best CGRP for migraines? ›
Nurtec ODT (rimegepant) is the first and only orally disintegrating tablet (ODT) CGRP antagonist. It can treat and prevent migraines in adults, and it's designed to work quickly. This is convenient if you need immediate relief from a migraine attack or have trouble keeping food or liquids down due to nausea.
Which is better, Ajovy or Nurtec? ›
Ajovy has an average rating of 5.5 out of 10 from a total of 327 ratings on Drugs.com. 39% of reviewers reported a positive effect, while 40% reported a negative effect. Nurtec ODT has an average rating of 6.3 out of 10 from a total of 300 ratings on Drugs.com.
Are Ubrelvy and nurtec the same thing? ›
Nurtec can also be used preventively for people with recurring migraine headaches. Though Ubrelvy and Nurtec belong to the same drug class, they come in different forms and have the potential for different dosing schedules.
What is FDA approved for migraine prevention? ›
The specific anti-seizure drugs that have FDA approval for migraine prophylaxis are: Depakote, Depakote ER (divalproex) Topamax, Qudexy XR, and Trokendi XR (topiramate)
Can Nurtec be used as a preventative? ›
Nurtec is the first oral calcitonin gene-related peptide antagonist approved for both acute and preventative treatment of migraine.
What are the criteria for rimegepant? ›
Background: The criteria defined by NICE is: NICE TA 906 - Rimegepant for preventing migraine: Rimegepant is recommended as an option for preventing episodic migraine in adults who have at least 4 and fewer than 15 migraine attacks per month, only if at least 3 preventative treatments have not worked.
Is rimegepant the same as rizatriptan? ›
Nurtec ODT (rimegepant) and Maxalt (rizatriptan) are used to treat migraine headaches. Nurtec ODT and Maxalt belong to different drug classes. Nurtec ODT is a calcitonin gene-related peptide receptor antagonist and Maxalt is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
