Ubrogepant (Ubrelvy), a new type of drug to treat acute migraines is approved by the FDA
Ubrogepant (Ubrelvy) is the first oral anti-CGRP drug to be approved by the FDA for the acute treatment of migraine attacks. It was developed by Allergan, manufacturer of Botox, the safest and arguably the most effective preventive treatment for chronic migraines. Allergan took a risk and bought this drug from Merck after Merck ran into problems developing a similar drug, telcagepant. Fortunately, ubrogepant had none of telcagepant’s problems and it was shown to be safe and effective in two large double-blind placebo-controlled trials.
The FDA-approved package insert says that, UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. The recommended dose is 50 mg or 100 mg taken as needed. If needed, a second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. It can be taken with or without food. The most common side effects were nausea, seen in 2% of those receiving placebo, 2% of those on 50 mg of ubrogepant and 3% of patients taking 100 mg. The second most common side effect was somnolence, present in 1% of patients taking placebo, 2% of those taking 50 mg and 3% taking 100 mg.
Such a low incidence of side effects is extremely rare with oral drugs, but we also see this with injectable anti-CGRP drugs that are used for the prevention of migraines. The second oral anti-CGRP drug, rimegepant which is awaiting FDA approval, also seems to have very low rates of side effects, which is very reassuring.
The average cost of developing a new drug is $2.6 billion, which means that by necessity new drugs are expensive. This means that insurance companies will require that migraine patients first try and fail generic versions of triptans, such as sumatriptan (Imitrex) or have a contraindication to taking a triptan. Contraindications for the use of triptans include cardiovascular disease (coronary artery disease, strokes, heart attacks, etc.), uncontrolled hypertension, and a few other. Fortunately, ubrogepant can be safely used in such patients.
Oral triptans work well in about 60% of patients, which leaves millions of migraine sufferers without an effective abortive therapy and for these patients, the introduction of ubrogepant could be life-changing.
We do know that migraine predisposes patients to a dissection of arteries, however we do not have evidence beyond a few case reports that triptans do that.
Hi doctor.
Thank you for the info. I noticed a comment above with regards to vessel dissection associated w triptans. I’ve been on sumatriptan for decades. 2 years ago I suffered a vertebral artery dissection. No one knows why and I’m now on aspirin for life. I’ve seen several doctors including a stroke specialist at Columbia.
Do you have thoughts on this?
It is not unusual for AImovig, Ajovy or Emgality to wear off before the end of the month. I recommend to my patients to take these injections as soon as the effect wears off, even it is after 3 weeks. The insurance will not pay for more than one a month, so I provide them with a free sample. We have a fourth drug in this family, Vyepti which is given intravenously every three months, but we haven’t had enough experience to know if it will also have an early wearing-off problem.
Ubrelvy has done zip for my migraine headaches. I have been forced, during the wait for relief, to go ahead and use my Imitrex injection for relief. I use Aimovig monthly as a preventive and it is awesome, but seems to be wearing off sooner every month. I have taken it for a year now.
I also have Maxalt and Esgic on hand for pain, but have used fewer and fewer of all the pain meds in teh last year with the monthly Aimovig.
Yes, it is probably safe to take a triptan and a CGRP drug such as Ubrelvy or Nurtec since we do combine injectable CGRP drugs with triptans.
There don’t seem to be any bad interactions between between Ubrelvy and triptans known. Do you think it would be safe to take both?
Yes, you are right. Ajovy or one of the other 3 CGRP monoclonal antibodies (Aimovig, Emgality, and Vyepti) could be very effective for people who respond to Ubrelvy or Nurtec. It is not clear though whether patients who don’t respond to Ubrelvy or Nurtec could still benefit from the injections. This is possible since some patients may not absorb oral medications well. Another common question is about taking Ubrelvy or Nurtec for breakthrough migraines on top of an injectable. It also makes sense to try this strategy since we know that the injectables do not completely block all CGRP and it is possible that during an attack there is still excess CGRP being released.
Hi Dr. Mauskop, I’ll be trying Ajovy for the first time (after having great success with Ubrelvy as an abortive). Since Ubrelvy works on the CGRP receptor and Ajovy works on the molecule itself, theoretically, do these two have a greater chance of working together (rather than if both meds competed for the same action, e.g. Ubrelvy and Aimovig)? Thanks in advance for your response!
Ubrelvy is the most astonishingly effective abortive I’ve ever taken in 40+ years—and over the years, I’ve tried dozens of preventives and abortives. Within two hours I was significantly free of the pulsating, throbbing head pain, occipital sharp jabbing, neck/shoulder stiffness, nausea, and was left only with a mild ache (though I started to feel it working within 20 min). I’ve taken only the 50mg dose, though the 100mg is likely to be more effective (but I’m trying to conserve my pills for the duration of the month). The only side-effect–a bit drowsy—no big deal. Btw, the shocking thing: I take two daily concurrent CYP3A4 Inducers, which reduces the availability of Ubrelvy in my system—and it still works! Because I’m heartened with the effectiveness of the CGRP mechanism, I’m now going to try Ajovy. Very excited and hopeful … and grateful to the developers of these meds!
I took this drug three times on the advice of my doctor who felt it was the new miracle medicine and sadly it made me very very nauseous. Additionally, it made me very tired. On the 2nd try I took it twice 2 hours apart. By then the migraine must have advanced and I finally took my imitrex. But too late. off to the ER. Not taking this again. Did not work for me.
Thank you, Dr. Mauskop.
This is a rare condition, but it’s possible that triptans can cause a dissection in someone who has weak vessel walls and is predisposed to dissection. One such condition is fibromuscular dysplasia. However, considering that many millions of people have taken triptans, the risk of dissection is probably very low.
Hello Dr. Mauskop. I have been on triptans, maybe 17 times a month for almost three decades (oral imitrex) and just read an article in my Google newsfeed, about a woman in her 50s who developed SCAD, apparently due to “overuse” of her triptan. She suddenly felt discomfort in her chest and went to the hospital, which saved her life. She was very healthy, not overweight, worked out, etc. I started looking at SCAD and triptans and found a few women of all ages who developed it after using triptans. (Anyone reading this who doesn’t know what SCAD is, it stands for Spontaneous Coronary Artery Dissection, where part of the lining of the artery comes away, either causing blockage or causing clots that give rise to a heart attack. It is extremely dangerous, often lethal. Is there any direct cause in your opinion, Dr. Mauskop? A lot of anecdotal evidence suggests a connection. I am very concerned as I start migraines 3 – 4 times a week. Ubrogepant isn’t yet available in Canada.
Thank you for your response. I think I am somewhat afraid that Imitrex will stop working for me at some point, and I want to have a backup option readily available that I know is effective for my headaches. One significant benefit to Imitrex, however, is that the generic version is available from Costco Pharmacy for only $2/pill. Thanks again for this valuable blog.
If Imitrex gives “great results and no side effects”, there is no reason to try Ubrelvy. But only by trying it you will find out if it works for you or not. It is possible that the response could vary among patients who are already on Emgality, Ajovy, or Aimovig.
What would be the reason that it might not be effective for patients who are already taking Emgality or a similar drug? Is it because CGRP is already being acted upon and further action may not be helpful? I have been taking Emgality for six months with very good results. But I still get 6-10 headaches per month and I’ve been thinking about asking my neurologist for a prescription for Ubrelvy because one of the triptans I take (Zomig) makes me so fatigued. I still get great results and no side effects from Imitrex, but I’d like to have another option for acute pain relief besides Zomig. Thank you for maintaining this blog; it is an excellent resource.
It will be safe, but we don’t know if it’s going to be effective.
Hi Dr. Mauskop. Will this be safe to take if you are already on a CGRP preventative (Aimovig, Emgality or Ajovy)?