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A Modern Oral Treatment for Acute Migraine in the USA

Ubrelvy (ubrogepant) is an oral medication available in the USA for quickly stopping migraine attacks. It's a CGRP inhibitor that works differently than triptans, offering a new option for relief.

Migraine is a complex neurological disorder that affects millions of adults in the United States, often leading to severe headache pain, nausea, vomiting, and extreme sensitivity to light and sound. For many years, triptans were the primary class of prescription medications used to treat acute migraine attacks.


While effective for many, triptans are not suitable for all patients, particularly those with certain cardiovascular conditions, or they may simply not provide sufficient relief. The introduction of Ubrelvy (ubrogepant), marketed by AbbVie, has marked a significant advancement in acute migraine treatment in the USA, offering a new and distinct approach to stopping migraine attacks.

Understanding Ubrelvy: A CGRP Receptor Antagonist (Gepant)

Ubrelvy belongs to a new class of migraine medications known as calcitonin gene-related peptide (CGRP) receptor antagonists, often referred to as "gepants." Unlike triptans, which work by constricting blood vessels and affecting serotonin pathways, Ubrelvy's mechanism of action is distinct:

  • Targeting CGRP: Calcitonin gene-related peptide (CGRP) is a protein found in nerve endings throughout the body, including the brain. During a migraine attack, CGRP is released and is thought to play a crucial role in the pain, inflammation, and dilation of blood vessels that characterize migraine symptoms.
  • Blocking the Receptor: Ubrelvy works by blocking the CGRP receptor, preventing CGRP from binding to it and initiating the cascade of events that leads to a migraine. By directly interfering with the CGRP pathway, Ubrelvy helps reduce migraine pain and associated symptoms without causing blood vessel constriction. This non-vasoconstrictive mechanism is particularly important for patients who cannot take triptans due to cardiovascular concerns.

Indications and Administration in the USA

In the USA, Ubrelvy is FDA-approved for the acute treatment of migraine attacks, with or without aura, in adults. It is important to note that Ubrelvy is not indicated for the preventive treatment of migraine; it is used specifically to stop a migraine attack once it has started.

Ubrelvy is an oral tablet available in two strengths: 50 mg and 100 mg. The typical dosing for Ubrelvy is to take one tablet (50 mg or 100 mg) by mouth as soon as possible after the onset of a migraine attack. If the migraine does not completely go away after the first dose, or if it goes away and then returns, a second dose may be taken at least two hours after the first dose. The maximum recommended dose in a 24-hour period is 200 1 mg. It's not recommended to treat more than 8 migraines in a 30-day period due to limited safety data on more frequent use.  

1. www.sterisonline.com

 

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Efficacy and Performance of Ubrelvy

Clinical trials have demonstrated Ubrelvy's efficacy in providing pain relief and freedom from the most bothersome migraine symptoms (such as nausea, sensitivity to light, or sensitivity to sound) within two hours of taking a dose. Many patients experience relief sooner, often within one hour.

Compared to triptans, Ubrelvy offers:

  • Similar Efficacy: Studies have shown that both triptans and gepants like Ubrelvy are effective in the acute treatment of migraine.
  • Different Side Effect Profile: Ubrelvy is generally associated with fewer side effects than triptans, particularly avoiding the vascular side effects (like chest tightness or pressure) that can be a concern with triptans. This makes Ubrelvy a valuable option for patients with cardiovascular risk factors or those who experienced side effects from triptans.
  • No Risk of Medication Overuse Headache: Unlike some acute migraine treatments, Ubrelvy has not been shown to cause medication overuse headaches (also known as rebound headaches) in clinical trials.

Potential Side Effects and Important Considerations

While generally well-tolerated, Ubrelvy does have potential side effects:

  • Common Side Effects: The most frequently reported side effects are nausea and sleepiness/tiredness. Dry mouth may also occur. These are typically mild.
  • Serious Side Effects (Rare): Serious allergic reactions, including hives, swelling of the face or throat, and difficulty breathing, are rare but possible. Patients should seek emergency medical help if they experience signs of a severe allergic reaction. New or worsening high blood pressure and Raynaud's phenomenon have also been reported in some cases.
  • Drug Interactions: Ubrelvy is metabolized by certain liver enzymes (primarily CYP3A4). Therefore, it can interact with other medications that affect these enzymes. Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice) are contraindicated, and dose adjustments are necessary with moderate or weak CYP3A4 inhibitors or inducers. Patients should always inform their healthcare provider about all medications, vitamins, and herbal supplements they are taking.
  • Kidney and Liver Impairment: Dose adjustments may be necessary for patients with severe kidney or liver problems. Ubrelvy is generally avoided in patients with end-stage kidney disease.
  • Pregnancy and Breastfeeding: The safety of Ubrelvy during pregnancy and breastfeeding is not fully established. Patients should discuss the risks and benefits with their doctor.

Access and Cost in the USA

Ubrelvy is a brand-name prescription medication, and as such, it can be expensive. The cash price for a supply of Ubrelvy in the USA can be over $1,000 for 10 tablets. However, various programs are available to help manage costs:

  • Insurance Coverage: Most commercial insurance plans, Medicare Part D, and some Medicaid plans cover Ubrelvy. However, prior authorization may be required, and co-pays can vary.
  • Manufacturer Savings Programs: AbbVie offers savings cards and patient assistance programs for eligible commercially insured patients, potentially reducing the out-of-pocket cost significantly, even to as little as $0 per month for some.
  • GoodRx and Other Discount Cards: These can offer discounts on the cash price at participating pharmacies.

In the evolving landscape of migraine treatment, Ubrelvy provides a significant option for adults in the USA seeking rapid, effective, and non-vasoconstrictive relief from acute migraine attacks. Its unique mechanism of action offers a crucial alternative for patients who cannot tolerate or do not respond to traditional therapies, contributing to improved quality of life for many migraine sufferers.

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