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Approvals for Migraines

March 9, 2020

Background
In the United States, it is reported that over 38 million people have been diagnosed with a migraine disease and some even believe that this number may be higher up to 50 million. On the other hand, some studies have also reported about 12 percent of adults in America have migraines and 4 million have chronic migraines.^1,2 A migraine headache is considered to be a chronic and complex condition in which an individual experiences substantial throbbing pain or a pulsating sensation that can occur on one side of the head. The associated symptoms of a migraine can include nausea, vomiting, aura, light sensitivity, or sound sensitivity, to name a few. Each person can experience it differently and relief can be achieved differently as well. The majority of migraines occur in women, with women being more than twice as likely to experience than men.³ Additionally, migraines tend to occur in individuals between the age of 15 to 55 or in those who may be uninsured.

Impact of Migraines
Migraines are known to be debilitating to sufferers and have the potential to significantly impact quality of life. It is the third most prevalent and sixth most disabling illness around the world. As a result of the development of a migraine, an individual can miss out on work or is unable to appropriately function. People who experience migraines can spend a greater amount on healthcare compared to those who do not experience migraines. Migraines have the potential to affect sufferers in a variety of ways throughout various facets of their lives.⁴ Also, the underdiagnosis and undertreatment of the condition can also significantly impact the debilitating effects of a migraine on an individual.⁴

Existing Therapeutic Options
In an effort to achieve some degree of control over migraine symptoms, there have been the development of preventative and treatment measures. The preventative approach to migraines seeks to yield fewer migraines, make them less intense, and shorter in duration. The use of preventative migraine medications are typically reserved for people who have 4 or more migraines a month and the medications that are used to relieve the migraines produce intolerable effects. Examples of some preventative migraine medications include anti-seizure drugs (e.g., topiramate and valproic acid), beta blockers (e.g., metoprolol, propranolol, timolol), or antidepressants (e.g., amitriptyline or venlafaxine).⁵ When it comes to treatment approaches, the triptans (e.g., sumatriptan, rizatriptan, almotriptan) are widely utilized for their impact on providing pain relief through effects on serotonin level. Another therapeutic option for management is botulism toxin which can provide relief to those people who suffer from migraines at least 15 days per month.⁵

Newer and Novel Treatments
Given the crippling impact that migraines can have on functionality, it can prove to be reassuring for sufferers when newer options for treatment are released on the market. One of the more recent approvals is Nurtec (Rimegepant), the first and only calcitonin gene-related peptide (CGRP) receptor that is available as a fast acting orally disintegrating tablet (ODT).⁶ A single 75mg dose of Nurtec ODT is believed to provide quick relief and return to normal functioning within 60 minutes of administration.⁶ Another agent that recently received approval for the preventative treatment of migraines and will be available in April 2020 is Vyepti (Eptinezumab-jjmr). What makes Vyepti particularly unique is the delivery as an intravenous formulation which many migraine medications do not come as for migraine prevention.⁷ The efficacy and safety of Vyepti was shown in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.⁷ The approval of these two agents provide additional hope for individuals who continuously suffer from migraines and while there is currently not a cure, the number of symptom free days are being increased with these drugs.

References

Burch, R, Rizzoli P, & Loder E. (2018). The prevalence and impact of migraine and severe headache in the United States: Figures and trends from government health studies: Headache. The Journal of Head and Face Pain. 58(4), 496-505.
Migraine Facts. Migraine Research Foundation. 2020. Retrieved from https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed February 28, 2020.
Mayo Clinic (2020). Migraine. Retrieved from https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201. Accessed February 28, 2020.
Burton, W. N., Landy, S. H., Downs, K. E., & Runken, M. C. (2009). The impact of migraine and the effect of migraine treatment on workplace productivity in the United States and suggestions for future research. Mayo Clinic proceedings, 84(5), 436–445. https://doi.org/10.1016/S0025-6196(11)60562-4
WebMD. (2020). How to prevent migraine headaches. Retrieved from https://www.webmd.com/migraines-headaches/guide/understanding-migraine-prevention#1. Accessed February 28, 2020.
Biohaven Pharmaceuticals. (2020). Biohaven’s nurtec ODT (Rimegepant) receives FDA approval for acute treatment of migraine in adults. Retrieved from https://www.biohavenpharma.com/investors/news-events/press-releases/02-27-2020?fbclid=IwAR3KFTUIFaoxo-L0o40jsqIE4EJPhuluwDOg9qMJrcadyXUpmd5lXQvWr-U. Accessed February 28, 2020.
Lundbeck (2020). FDA approves Lundbeck’s Vyepti (eptimezumab-jjmr)-the first and only intravenous preventative treatment for migraines. Newsroom. Retrieved from https://www.newsroom.lundbeckus.com/news-release/2020/fda-approves-lundbecks-vyepti-eptinezumab-jjmr-for-migraine?fbclid=IwAR0ynKnD1sVkuKQ-9CM9bK0o61Fo6OOQ_HXUWEvi5NDT1una9sNbtrUDuEo. Accessed February 28, 2020.