Ubrelvy: Ushering in a New Era of Migraine Abortives
Hot on the heels of Eli Lilly‘s first-in-class migraine abortive, Reyvow, comes Ubrelvy by Allergan.
Ubrelvy, also known as ubrogepant, is a CGRP receptor antagonist that targets the CGRP receptor site. It is the first “gepant“ to receive FDA approval in this exciting time for migraine treatment, a time that is seeing a rapid change in the treatment landscape.
An exciting time for migraine treatment
It is strange to consider that there would ever be an “exciting“ time to have migraine. However, for a disease that has not had any new abortive medications for over three decades this really is pretty amazing!
Ubrelvy is a groundbreaking development in migraine treatment that has a very different mechanism of action than the triptans, dihydroergotamine (DHE), and Reyvow. Triptans specifically block the serotonin receptors 5-HT1B and 1D. DHE, an ergot alkaloid, attaches to the pain receptors in the brain and nerves. Reyvow, a serotonin receptor agonist, binds to the 5HT1F receptors.
How is Ubrelvy different from other treatments?
In contrast, Ubrelvy, a CGRP receptor antagonist, inhibits the CGRP pathway rather than impacting the serotonin or pain receptors. This helps explain the completely different side effect profile. It also means that Ubrelvy offers much-needed hope to those who can’t take specifically triptans or DHE due to cardiovascular and cerebrovascular conditions.
So why is Ubrelvy such an exciting new development in the abortive treatment of migraine?
- It is the first abortive to specifically target the CGRP pathway
- It appears to have remarkably few side effects, with the most frequent being nausea, somnolence and dry mouth.1 It was generally very well tolerated by patients in the clinical trials.
- In clinical trials it was able to provide relief from migraine pain within two hours for many people. It also was able to stop the “most bothersome symptom” (nausea, photosensitivity, phonosensitivity).
- It does not have vasoconstrictive effects. This means it is more likely to be safe for people who have cardiovascular conditions. This is something that has been a huge concern with the older abortive medications.
- It does not appear to put people at risk for medication overuse headache (MOH). This is a huge factor to consider. That is especially true for those who have more than 8-10 severe migraine days each month and exceed the recommended doses recommended per month.
- The trials included patients from ages 18-75. This is great news for those over 65 who are often excluded from clinical trials.
How did Ubrelvy do in clinical trials?
There have been some very encouraging clinical trials with positive results including the ACHIEVE I2 and ACHIEVE II3 trials. The data from these trials reinforce the efficacy of the acute treatment of migraine with ubrogepant.
Compared with placebo, it led to significantly greater rates of both pain freedom and “most bothersome migraine-symptom” freedom at two hours with both tested doses (50mg and 100mg).
Common concerns in the migraine community
One of the biggest concerns in the migraine community has been access to abortive medications that are safe for those with cardiovascular conditions to take. This is particularly important bearing in mind that around 20% of people with migraine have cardiovascular disease and cannot take triptans or DHE.
A second concern has been to find medications that are both effective and tolerable. Sadly, as many as 30% of people with migraine who take triptans find that they do not help or experience intolerable side effects.4
It is comforting to know that in the ACHIEVE II trial “approximately 11 percent of participants had moderate to severe CV risk factors, and 23 percent of participants previously had an insufficient response to triptans.”5 Those with clinically significant cardiovascular or cerebrovascular disease were excluded.
Promising results, more to learn
For those people who have been without an effective or tolerable abortive for years or even decades, the FDA approval of Ubrelvy is really encouraging! As always, further studies are needed to look into the safety profile for the large percentage of the migraine community which has either cardiovascular and/or gastrointestinal conditions.
In addition, with so many women of childbearing age living with migraine, it remains to be seen whether Ubrelvy is safe to take either during or immediately prior to pregnancy.
When will Ubrelvy be available?
However, setting aside the need for ongoing real-world trials with these populations, as well as the unknown pricing at this time, as Ubrelvy is about to be available on the market there is a notable air of excitement in the migraine community. It normally takes about four to five weeks from FDA approval for a new medication to be available, so we can expect that excitement only to grow over the coming month.
An era of (informed) hopefulness
It is undeniable that for the first time in decades there is an atmosphere of hopefulness for many who either live with migraine or who help treat it. Perhaps a good approach would be that of “informed hopefulness.” We’re hopeful that:
- Ubrelvy will provide a much-needed migraine abortive option for a disease which has been sorely lacking for so long.
- Those who live with migraine and currently have inadequate treatment will be able to regain some of their lives.
- This truly is the start of a new era for migraine, a disease that impacts around one billion people worldwide.
However, in the midst of hopefulness we stay informed about:
- The current body of research
- The upcoming impact of this exciting new medication
- Any new developments discovered through real world use
Grateful for this hope
As people living with migraine we recognize that there is the beginning of a breath of fresh air at last, and we are so very grateful to those doctors and researchers who are dedicating their lives to help make a difference!
Does Ubrelvy represent hope to you? Is this a medication that you are interested in trying? Do you have migraine abortive medications that are both effective and tolerable?
How much has your migraine disease changed or evolved over time?