The director of the Medstar Georgetown University Headache Center spoke about the data that’s been presented thus far, as well as how ubrogepant separates itself from what’s currently available for patients.
Jessica Ailani, MD, a neurologist and the director of the Medstar Georgetown University Headache Center
Jessica Ailani, MD
The FDA recently accepted a New Drug Application (NDA) for ubrogepant, an investigational acute treatment for migraine in adult patients, developed by Allergan. The treatment is a member of the gepant medication class, as an oral calcitonin gene-related peptide (CGRP) receptor antagonist.
When the NDA was accepted, Jessica Ailani, MD, a neurologist and headache specialist, noted that despite the prevalence and burden of migraine, it remains a widely untreated disease, marking ubrogepant’s step closer to FDA approval as a welcome one. Especially so because the treatment, if approved, would be the first novel acute treatment for migraine in more than a quarter century.1
To find out more about the CGRP receptor antagonist, NeurologyLive® spoke with Ailani in an interview. She discussed some of the data that’s been presented thus far, as well as how ubrogepant separates itself from what’s currently available for patients.
Jessica Ailani, MD: Basically, anytime I’m evaluating a study for an acute migraine treatment, there are a few things I want to know before I want to talk to my patient about it. Did it achieve its primary endpoint at all, which often is 2-hour pain-freedom? Looking at secondary end points, how do patients feel in 2 hours of relief? How are they doing with most bothersome symptoms— distortive nausea, light sensitivity, whatever the patient finds most bothersome to them? Do they have a reduction in those symptoms in 2 hours? To me, those are the first 3 things that I will look at when I’m looking at a study. Ubrogepant met all those end points. A good portion of patients, higher than placebo, met freedom at 2 hours, had pain relief in 2 hours, and had a reduction in most bothersome symptoms in 2 hours.
Then, I tend to look at how well tolerated it is. What were the adverse effect profiles? The patients will often ask, “If this works, well, what about the adverse effects? If I take this, is it going to help my migraine but then I’m going to be in bed because it’s going to make me feel terrible? Again, ubrogepant had a very low adverse effect profile, and I thought that was really promising. When I’m looking at a new treatment for a patient, if it’s effective and it comes with a low adverse effect profile, this might be a good option for patients to have. Those are the things that I would look at, and those are the things that stand out in the data points for ubrogepant.
What makes it unique is that it’s a different category of medication. It’s working on the calcitonin gene-related peptide, where right now in that space we have monoclonal antibodies that are used as preventive treatment options. Ubrogepant is a new treatment that is used at the start of migraine onset, so it has a novel mechanism of action compared to what’s currently available. The gold standard for most patients having an acute migraine attack is to be given a triptan—that’s working on an entirely different mechanism of action than a medication like ubrogepant. Not everybody responds to triptans, so it’s nice to have a different mechanism of action because the thought is that if something’s not working, their migraine might be working in a slightly different mechanism. So, to have a drug that’s available to patients that works on a different mechanism, means you’re going to treat some patients in a different way when nothing was working in the past. That’s what makes it different from what’s available right now, and what makes it unique is its mechanism of action. It’s the CGRP receptor antagonist and it’s blocking the receptor, but it’s an oral pill. It’s taken as soon as the migraine starts, and you can take another dose as needed. At least that’s how it’s being studied right now.
Right now, it’s being studied in patients with episodic migraine as an acute treatment option. I don’t know if there’s going to be other mechanisms it will be studied for, and it’s hard to say if a CGRP mechanism would work for other headache disorders as well. That’s something, as providers, we are interested in, but we I like to see an investigation before we start using it in a patient without understanding if it’s going to work or not. And as a clinician, when I look at patients that we treat, migraine is probably one of the more prominent headache disorders that we treat, but cluster headache is a more difficult disorder and we sometimes we run out of treatment options. It would be nice to see studies in the future, once drugs like this get approval, to see if this would this be effective in a slightly different mechanism of action. But I can’t say if they’re going to be looking at that for sure—it would be nice to see that information.
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.