Migraine

Migraine can disrupt every aspect of a person's life.

The burden of migraine can impact relationships, careers, and mental health.

Prevalence and burden of migraine

Migraine is one of the most prevalent and disabling neurological diseases, affecting about one billion people worldwide.

In the US, >40 million people have migraine, resulting in >2 million disability-adjusted life-years.

Adding to the burden of migraine is unseen suffering and disability, and stigma. Many patients appear ok in the midst of a migraine attack but can be significantly incapacitated.

Characteristics of migraine

Migraine is a complex neurological disease involving throbbing/pulsating headache pain associated with a range of symptoms such as sensitivity to light (photophobia) and sound (phonophobia), nausea, vomiting, and inhibition of gastric emptying (gastric stasis).

Migraine disproportionally impacts women (about 3:1 female:male prevalence ratio) and is frequently associated with other female prevalent conditions such as dysmenorrhea, fibromyalgia, chronic pelvic pain, and endometriosis.

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Acute treatments for migraine

Acute treatments for migraine are taken after a migraine attack has started to reduce or stop headache pain and associated symptoms. They are the bedrock of migraine treatment and indicated for all people with migraine, regardless of attack frequency, both in episodic migraine (less than 15 headache days per month) and in chronic migraine (15 or more headache days per month). They are used both as standalone acute therapy and concomitantly with preventive treatments for breakthrough migraine attacks.

Existing CGRP-targeted therapies

CGRP-targeted therapies for the acute treatment of migraine consist of small molecule CGRP receptor antagonists, a.k.a. gepants, available as either oral or intranasal formulations, taken as needed, after a migraine attack has started to reduce or stop headache pain and associated symptoms.

While gepants have significantly improved the standard of care for the acute treatment of migraine by bringing forward safer and better tolerated treatment options than triptans, they can have slow, modest, and variable efficacy.

Persistent unmet medical needs for the acute treatment of migraine

Patients and healthcare providers (HCPs) must choose between higher efficacy or better tolerability for the acute treatment of migraine but cannot have both in the same medication. Patients and HCPs are still seeking better medicines that deliver fast speed to relief and high and consistent efficacy, combined with improved safety and tolerability.

Limitations of current acute treatments for migraine

Triptans and gepants are the two most prescribed drug classes amongst medications specifically approved for the acute treatment of migraine.

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Triptans are generally more efficacious but less tolerated than gepants, and associated with significant contraindications, warnings, and risk for medication overuse headache. Conversely, gepants are safe and generally better tolerated but have lower efficacy than triptans.

For the acute treatment of migraine, the route of administration greatly impacts speed to relief and the ability to reduce associated symptoms, irrespective of drug class.

Oral migraine medications tend to have slow onset of action and modest efficacy, along with unpredictable response from attack to attack, due to the inconsistent absorption of oral drugs. Currently available injectable treatments work faster and better than oral medicines but are often poorly tolerated, contributing to high discontinuation rates.

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References

GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurology 2018; 17: 954–76.
Aurora, SK, Kori, SH, et al. Gastric Stasis in Migraine: More Than Just a Paroxysmal Abnormality During a Migraine Attack. Headache: The Journal of Head and Face Pain, 2006, 46: 57-63.
Aurora SK, Papapetropoulos S, et al. Gastric stasis in migraineurs: etiology, characteristics, and clinical and therapeutic implications. Cephalalgia. 2013 Apr;33(6):408-15.
Lipton RB, Bigal ME et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology, 2007, 68(5):343-349.
Mannix LK. Menstrual-related pain conditions: dysmenorrhea and migraine. J Womens Health (Larchmt). 2008 Jun;17(5):879-91.
Penn IW, Chuang E, et al. Bidirectional association between migraine and fibromyalgia: retrospective cohort analyses of two populations. BMJ Open. 2019 Apr 8;9(4):e026581.
Karp BI, Sinaii N, et al. Migraine in women with chronic pelvic pain with and without endometriosis. Fertil Steril. 2011 Mar 1;95(3):895-9.
Yang MH, Wang PH, et al. Women with endometriosis are more likely to suffer from migraines: a population-based study. PLoS One. 2012;7(3):e33941.
Lipton RB, Marcus SC, et al. Acute treatment patterns in patients with migraine newly initiating a triptan. Cephalalgia. 2020 Apr;40(5):437-447.
IQVIA TRx data, December 2023.
Karlsson W K, Ostinelli E G, et al. Comparative effects of drug interventions for the acute management of migraine episodes in adults: systematic review and network meta-analysis BMJ 2024; 386 :e080107.
Yang CP, Liang CS, et al. Comparison of New Pharmacologic Agents With Triptans for Treatment of Migraine: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Oct 1;4(10):e2128544.
Lipton RB, Munjal S, et al. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018 Oct;58(9):1408-1426.

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