by Stephanie J. Nahas, MD, MSEd, FAHS, FAAN

It’s exciting to have this second-in-class new medication for the acute treatment of migraine attacks in adults. Of course, just because the US Food and Drug Administration approves a new therapy, that doesn’t mean we should accept it as broadly suitable without examining the evidence for its efficacy, tolerability, and safety. Here we are provided with strong evidence that rimegepant provides rapid relief, is well tolerated, and is safe in appropriate individuals. But how might this translate to a significant impact in practice?

We’re all familiar with the old advice given to patients in the throes of a migraine attack: “Take two and call me in the morning.” Of course, in time we’ve come a long way in perfecting migraine management, and it’s far from so simple. It’s well-established that patients need options when it comes to managing attacks, to be able to stratify their care as well as to do it safely.1 By now, we have a multitude of both FDA-approved or -cleared and evidence-based remedies for migraine attack management, both pharmacologic and non-pharmacologic, and which work through a variety of mechanisms of action. So why would we need yet another treatment, let alone a second one from the same family?

Despite the numerous options available until this year, there remain many patients who cannot tolerate, cannot take, or cannot afford most if not all effective therapies available to them. And even for those who have an action plan upon which they can rely, many are willing to try something new that might work better and more safely for them.2 In either case, this is where rimegepant may come in.

Rimegepant offers for both clinician and patient a simple approach with few adverse events and no medical contraindications. The only contraindication or warning is with respect to the possibility of hypersensitivity reaction, something which isn’t unique to the molecule and which occurred in under 1% of clinical trial participants. While drug interactions are almost always a concern with any medication to one degree or another, for rimegepant, it’s straightforward to ascertain and not an issue in most cases.

When patients are queried about what they want from a treatment intended to treat migraine attacks, the vast majority endorse pain elimination and rapid onset of relief as their highest priorities.3 Tolerability is also of great importance, as is duration of effect and simplicity of use. Rimegepant shows statistically significant and clinically meaningful superiority over placebo with respect to pain relief, pain freedom, and freedom from the most bothersome associated attack symptom. Furthermore, rimegepant displays a side effect profile similar to placebo, with only the symptom of nausea meeting reporting threshold and at a low rate. Also, the data support the claim that relief may be sustained for up to 48 hours. Lastly, this is a treatment which is compatible with almost every other acute medication available (the exception being ubrogepant from the same class), allowing patients the ability to use it not only as a standalone, single, orally-disintegrating dose, but also in combination with other medications or as a rescue therapy.

Rimegepant may not be suitable for all patients, of course. In particular, it has not been studied in pregnant or lactating women or in patients with active vascular or psychiatric disease, among other populations. It’s always wise to exercise caution with new therapies, but there are millions of American adults with migraine who may now benefit further and suffer less thanks to rimegepant.

 

References

1. Tepper SJ. Acute Treatment of Migraine. Neurol Clin 2019;37(4):727-742.
2. Bigal M, Rapoport A, Aurora S, Sheftell F, Tepper S, Dahlof C. Satisfaction with current migraine therapy: Experience from 3 centers in US and Sweden. Headache 2007;47(4):475-479.
3. Lipton RB, Stewart WF. Acute migraine therapy: Do doctors understand what patients with migraine want from therapy? Headache 1999;39(SUPPL. 2):S20-S26.