The migraine specialist spoke to the CGRP receptor antagonist’s potential impact on patients with migraine who have been lacking a novel acute treatment for some time.
Jessica Ailani, MD
From a preventive perspective, migraine treatment has arguably never been in a better state, with last year seeing 3 new calcitonin gene-related peptide (CGRP) inhibitors coming to market and another in front of the FDA this year. Although this has been to the delight of migraine specialists, the lack of novel options for acute migraine treatment has remained a challenge.
Jessica Ailani, MD, is one of the migraine specialists experiencing this test in her clinical practice. Despite their vast contraindications, triptans remain the top option for patients to take at the onset of migraine, though they fail to work for the majority. However, the gepant class has begun to move through the pipeline, with the first member, ubrogepant, recently being accepted for review by the FDA.
As the CGRP receptor antagonist could hit the market in the fourth quarter of 2019, NeurologyLive® spoke with Ailani to discover more about its potential impact and what it can bring to the table for physicians who are treating this patient population.
Jessica Ailani, MD: When it comes to clinical use and patient challenges, I don’t think this type of medicine or category of medications would be difficult for patients to use. We’re hopeful it will come with fewer contraindications because, with triptans, patients are often limited in that they have cardiovascular issues, so we don’t use those medications. For the gepants, the class in which ubrogepant is in, we’re hopeful that that cardiovascular indication won’t be an issue. We want to open the use of these patients who don’t have migraine-specific options right now.
When it comes to providers, one, I think there’s going to be an education factor. Meaning we need to educate providers who take care of patients with migraine what this new class is, what the new category is, and when to consider it as an acute option. But I honestly think in the end the biggest hurdle—which is always the biggest hurdle for any provider—is insurance coverage. This is going to be a new product with coverage challenges, and we have to fail with something before the patient can use this medication. It’s a horrendous shame, but this is the time we live in and this is a lot of what we have to deal with.
When we look at ubrogepant and the idea of these gepants, it’s been in development for some time with the idea of attacking the CGRP system and its role in migraine pathology. When you have studies that show that a molecule that’s working to reduce CGRP’s activity is effective in migraine, you’re just putting a lot more emphasis on the fact that CGRP does play a big role in migraine pathology. It’s exciting because it’s just adding to our knowledge base and it’s strengthening the knowledge that we’ve gained in the last several decades.
It plays along nicely with some of the preventative options that have come out that have really indicated that CGRP is the major player in migraine, and so we have a preventive option that works, and now, here’s an acute option that shows the same idea. If we reduce the activity of this protein, we’re going to have patients that are feeling better when they are having a migraine attack.
This is different than what we used to think, which was migraine was only a blood vessel problem and that there’s only 1 thing that occurs—if we fix it, everyone gets better. Here with these newer drugs showing that there’s probably more than 1 pathway and we need to have specific products for these different pathways to allow more patients to have different options, so they can find the right type of medications for them.
One thing that is important and that makes it really exciting to us as clinicians is that we’ve had all this great development in the last few years on the drug option side of things, where there’s been this whole new explosion of medications, but for acute treatment, it’s been a little bit lagging. It’s exciting to have the idea that in the next year or so, we might have new acute therapeutic options that aren’t just within the same realm of triptans—which don’t really work well for everybody. In this day and age, when we’re really trying to move away from non-specific treatment options to specific options that are safer to use and are actually treating the problems at hand, I think it’s really nice to see that we might have some more of these options for patients coming out in the next year.
1. Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine [press release]. Dublin, Ireland: Allergan. Published March 11, 2019. allergan.com/news/news/thomson-reuters/allergan-announces-fda-acceptance-of-new-drug-appl. Accessed March 11, 2019.