Abortive Treatments for Acute Migraine: Lasmiditan and CGRP Receptor Antagonists

Acknowledgements: The authors wish to acknowledge Matthew Bridgeman, MLIS, information and education librarian at Robert Wood Johnson Library of Health Sciences at Rutgers University, for his assistance in conducting the literature search for this article.

Prior Presentation: This work has been presented as a poster at the American Society of Health-Systems Pharmacists Midyear Clinical Meeting and Exhibition in December 2024; however, it is not currently under review at any other journal.

Introduction

Migraine is a common, functionally debilitating neurological disease that affects more than 60 million individuals in the US and 12% of the global population. In 2021, more than 4% of adults reported a significant degree of daily interruption by headaches or migraines, with a 3-fold higher prevalence among women than men, according to the CDC.¹ Migraines are the third most common illness in the world and the second most common neurological disorder, according to the World Health Organization.² Adults and children can experience migraine headaches, although migraines are 3 times more likely to be diagnosed in females than in males, due in part to hormonal fluctuations associated with the menstrual cycle.³ Overall, approximately 1 in 5 women, 1 in 16 men, and 1 in 11 children experience migraines worldwide.⁴ Migraines are the sixth highest cause of disability-adjusted life years worldwide, as reported in the Global Burden of Disease study.² If left untreated, a migraine can last between 4 and 72 hours, and individuals who experience migraines report worse health-related quality of life, higher levels of absenteeism from work, work impairment, and higher health care resource utilization than individuals who don't experience migraines.³

Migraine attacks are characterized by throbbing or pulsating pain on 1 side of the head. Other symptoms include nausea, vomiting, and sensitivity to light, sounds, and smells. Approximately one-third of patients experience a migraine aura, a sensory (usually visual) disturbance in which the patient experiences flashing lights, zigzag lines, blurred vision, or transient vision loss preceding the attack.⁵ Although the true etiology and underlying pathophysiology of migraine are not fully understood, multiple pathways have been suggested, including involvement of the trigeminovascular system and centrally mediated through predisposition to neuronal hyperexcitability.⁶ Calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase–activating peptide 38 (PACAP-38), neuropeptides associated with cerebral vasoregulation, have been identified in clinical models of migraine as potential small-molecule targets for treatment. Lastly, a genetic component is postulated to contribute, as well, given the prevalence of family history among those with the disorder.³

Pharmacists play a key role in caring for patients who experience migraines by providing education related to the condition, self-care, and management of acute migraine, and in ensuring proper medication use. In this article, we review the most recently approved prescription-only, oral targeted abortifacient therapeutic options used for the treatment of acute migraine, including lasmiditan (Reyvow; Eli Lilly and Company) and the CGRP antagonists atogepant (Qulipta; AbbVie), rimegepant (Nurtec ODT; Biohaven Pharmaceuticals), ubrogepant (Ubrelvy; AbbVie), and zavegepant (Zavzpret; Pfizer).

We acknowledge the widespread use of single-agent and combination analgesic medications, including acetaminophen, nonsteroidal anti-inflammatory agents, and antiemetics, that may be used for symptomatic relief of acute migraines of mild to moderate intensity.⁷ However, these agents have been reviewed extensively elsewhere and do not directly target the proposed underlying pathophysiology. As such, they fall outside the scope of this review.⁸ Likewise, serotonin receptor agonists, parenteral CGRP antagonists indicated for migraine prevention, neuromodulation, and nonpharmacologic approaches are discussed elsewhere in the literature.^9,10 Newer and emerging therapies have demonstrated improved efficacy in moderate to severe migraine management and offer new options to patients for whom traditional agents have been insufficient.^11,12

Serotonin 5-HT_1F Receptor Agonist: Lasmiditan

Lasmiditan, a first-in-class -ditan medication, was approved in the US in 2019 for the treatment of patients with acute migraine.¹³ This medication is a highly selective agonist of the 5-HT_1F receptor, which is expressed on central and peripheral trigeminal neurons; of note, this medication has a higher affinity for the 5-HT_1F receptor than for other serotonin receptor types, which may explain how agonists of this receptor exhibit analgesic effect during migraine without prompting local vasoconstriction.¹⁴ Lasmiditan is rapidly absorbed after oral administration, reaching a peak plasma concentration in 1.8 hours. However, taking it with a high-fat meal delays full absorption by approximately 1 hour. The medication exhibits 55% to 60% plasma protein binding and a mean half-life of 5.7 hours. It is primarily metabolized hepatically and extrahepatically via ketone reduction through the action of noncytochrome P450 enzymes. No significant differences were noted in the pharmacokinetics of lasmiditan based on age, sex, race, ethnicity, or body weight, though clinically insignificant increases in maximum concentration and area under the curve were noted among geriatric patients.¹³

Efficacy

Two phase 3 landmark studies of lasmiditan, SAMURAI (NCT02439320) and SPARTAN (NCT02605174), both demonstrated its superiority compared with placebo in achieving migraine pain relief.^15,16 The SAMURAI trial randomly assigned 2231 adult patients with a diagnosis of migraine 1:1:1 to lasmiditan 100 mg, lasmiditan 200 mg, or placebo.¹⁵ Patients used a diary to record their symptoms during migraine attacks; both lasmiditan dosages significantly increased the proportion of patients reporting freedom from headache pain within 2 hours of treatment with mild or moderate adverse effects (AEs; 100 mg: OR, 2.2; 95% CI, 1.6-3.0).¹⁵

The SPARTAN trial randomly assigned 2869 adults with a history of disabling migraine, including those with cardiovascular risk factors, 1:1:1:1 to lasmiditan 50 mg, 100 mg, or 200 mg, or placebo to evaluate the proportion of patients who were headache-pain free 2 hours after administration.¹⁶ All lasmiditan doses yielded significantly higher proportions of patients who were pain-free by the 2-hour threshold; the most common treatment-emergent AEs were dose-related dizziness, somnolence, and paresthesias.¹⁶

Safety and Tolerability

Lasmiditan has no known contraindications but may cause central nervous system (CNS) depression; patients should be counseled to avoid concomitant administration with CNS depressants; they also should avoid driving or operating heavy machinery for at least 8 hours due to potential sedation.¹³ Additionally, use of lasmiditan may be associated with serotonin syndrome; this medication should be discontinued if serotonin syndrome is suspected.¹³ The most common AEs are generally mild and include dizziness (9%-17%), nausea and vomiting (4%), and paresthesia (3%-9%).¹³ Unlike triptans, lasmiditan is a Schedule V controlled substance in the US due to abuse potential for possible euphoria.¹³

Dosing and Administration

The recommended dose of lasmiditan ranges from 50 mg to 200 mg as a single dose taken within 24 hours. Patients should refrain from taking lasmiditan if they cannot wait at least 8 hours after taking it before driving or operating machinery. Lastly, lasmiditan tablets should be swallowed whole, regardless of timing with food.¹³

CGRP Antagonists: Rimegepant, Ubrogepant, and Zavegepant

CGRP is a potent proinflammatory neuropeptide consisting of 37 amino acids. It functions as a vasodilator within cerebral arteries and is widely distributed throughout the central and peripheral nervous systems.¹⁷ By modulating vasodilation, CGRP is thought to increase reactivity of peripheral sensory neurons, which are crucial in the pathogenesis of migraine.¹⁸ Elevated serum levels of CGRP have been identified in patients during a migraine headache; exogenous CGRP has been shown to induce a migraine headache. Therefore, small-molecule CGRP antagonists were designed to counteract the acute migraine-triggering effects of CGRP that exert their effects on the calcitonin receptor-like receptor.^17,18

Multiple CGRP antagonist medications have been developed for the prevention of migraine and for acute migraine treatment. Monoclonal antibodies—erenumab-aooe (Aimovig; Amgen), fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals), galcanezumab-gnlm (Emgality; Eli Lilly and Company), and eptinezumab-jjmr (Vyepti; Lundbeck)—targeting the CGRP ligand were developed first, and each is FDA-approved for migraine prevention.^19-22 Additionally, all these agents are parenterally administered. Atogepant, a small-molecule CGRP antagonist, is only approved for the preventive treatment of migraine in adults; each of these agents is outside the scope of this review.²³ The other oral CGRP antagonists—rimegepant, ubrogepant, zavegepant—share a common indication for acute migraine treatment, although some also may be used preventively.^24-26

Efficacy

All the landmark phase 3 trials for the CGRP antagonists approved in the treatment of acute migraines utilized the same coprimary efficacy end point: freedom from pain and from the most bothersome migraine-associated symptom at 2 hours.

The phase 3 ACHIEVE I (NCT02828020) and II (NCT02867709) trials (N = 1672 and N = 1686, respectively) were randomized, double-blind, placebo-controlled trials conducted to evaluate the efficacy and safety of ubrogepant 25 mg, 50 mg, and 100 mg in adults with acute migraine.^27,28 In these studies, patients were randomly assigned to receive placebo or ubrogepant (50 mg or 100 mg in ACHIEVE I, and 25 mg or 50 mg in ACHIEVE II) to treat 1 migraine attack of moderate/severe headache pain intensity. In ACHIEVE I, a greater percentage of participants who received ubrogepant had freedom from pain and absence of the most bothersome migraine symptom at 2 hours than those who received placebo.²⁷ In ACHIEVE II, ubrogepant use was associated with significantly greater pain freedom rate at 2 hours with the 50-mg and 25-mg doses vs placebo; freedom from the most bothersome migraine-associated symptom at 2 hours was observed with the 50-mg dose only.²⁸

Rimegepant’s efficacy and safety were evaluated in 2 landmark clinical trials. In the first, a multicenter, double-blind, phase 3 trial (NCT03237845) of 1186 adults with a history of migraines for 1 year or longer and 2 to 8 migraine attacks of moderate to severe intensity per month were randomly assigned to receive rimegepant 75 mg as a single dose or placebo for the treatment of a single migraine attack.²⁹ In this trial, rimegepant use was associated with significant reductions in both the percentage of patients who were pain-free 2 hours after receiving the dose vs placebo, as well as those who were free from their most bothersome migraine symptom 2 hours post dose.²⁹ In a second double-blind, randomized, placebo-controlled, multicenter phase 3 trial (NCT03461757), 1466 adults with acute migraine were treated with rimegepant in a 75-mg orally disintegrating tablet or placebo. The single-dose rimegepant was superior to placebo in freedom from pain and freedom from the most bothersome symptom 2 hours post dose.³⁰

The efficacy of zavegepant was additionally demonstrated in 2 randomized, placebo-controlled trials.^31,32 The first, a randomized, placebo-controlled, dose-ranging phase 2/3 trial (NCT03872453) evaluated the efficacy of zavegepant nasal spray in treating acute migraine in 1673 adults.³¹ Participants were randomly assigned 1:1:1:1 to receive zavegepant nasal spray 5 mg, 10 mg, 20 mg, or placebo. Results indicate that, as a single dose of 10 mg or 20 mg, zavegepant was more effective than placebo (P = .0113) and had a favorable safety profile, with mild to moderate AEs that resolved without treatment.³¹ In a second double-blind, randomized, placebo-controlled, multicenter phase 3 trial (NCT04571060), the efficacy and safety of zavegepant nasal spray 10 mg were compared vs placebo in 1978 adults. Results suggest that zavegepant nasal spray, at a single 10-mg dose, was more effective than placebo, and it had a favorable safety profile; the most common AEs were dysgeusia, nasal discomfort, and nausea (P < .0001).³²

According to results from these trials, CGRP antagonists were generally well-tolerated, with notable AEs including nausea, sedation, and hypersensitivity. These agents have a number needed to treat (NNT) of 8 to 14, depending on the outcome and the medication used, suggesting that they are efficacious in acute abortive migraine treatment. Of note, a meta-analysis on the NNT and efficacy of the oral triptans has suggested the NNT may be in the 3 to 11 range, which would suggest CGRP antagonists may have comparable efficacy to this class.³³

Safety and Tolerability

Generally, CGRP antagonists are well tolerated and associated with minimal AEs when taken for the directed amount of time. The most common AE seen in the currently approved CGRP antagonists is nausea. No serious AEs were reported in any of the clinical trials conducted; however, recent postmarketing surveillance data have revealed additional safety concerns, including the emergence of Raynaud phenomenon and hypertension associated with use of these agents.^34,35

Ubrogepant and rimegepant should not be taken concomitantly with strong CYP3A4 inhibitors and inducers, as this can lead to alterations in concentration and decrease the efficacy of the medication. Ubrogepant is contraindicated with CYP3A4 inhibitors.²⁴ Use of rimegepant and zavegepant is contraindicated in individuals with hypersensitivity to the medication itself or any aspect of its formulation.^25,26 Patients taking ubrogepant specifically should be cautious of drug interactions with the administration of BCRP and/or P-gp only inhibitors, as this can increase the exposure of ubrogepant, which is a substrate of BCRP and P-gp efflux transporters.²⁴ Other commonly reported AEs include dry mouth and somnolence (each reported to occur in less than 5% of individuals in clinical trials).^25,26 Rimegepant hypersensitivity reactions can manifest as dyspnea and rash; use should be discontinued if these symptoms occur.²⁶ Zavegepant hypersensitivity reactions can manifest as facial swelling and urticaria; use should be discontinued if this occurs.²⁵ Zavegepant’s AE profile includes dysgeusia, nasal discomfort, nausea, vomiting, throat irritation, and increased concentrations of blood creatine phosphokinase.²⁵ Use of zavegepant with OATP1B3 or NTCP transporter inhibitors or inducers should be avoided. Use of the nasal spray should be separated from use of intranasal decongestants by at least 1 hour after zavegepant administration if avoidance is not possible.²⁵

Dosing and Administration

Medications in this class are available in various dosage forms and formulations. Ubrogepant and rimegepant are commercially available as oral tablets, whereas zavegepant is administered intranasally.^24-26 The indicated dosing of ubrogepant is 50 mg or 100 mg taken as needed for migraine pain relief; if a second dose is necessary, it should be administered at least 2 hours after the first dose, with a maximum 24-hour dosage of 200 mg.²⁴ Rimegepant is dosed at 75 mg taken once per day; the maximum daily dose is 75 mg, and the safety of more than 18 doses in a 30-day period has not been evaluated.²⁶ Finally, zavegepant is given as a 10-mg single spray into 1 nostril. The maximum dose is 1 spray per day; safety in treating more than 8 migraines within a 30-day period is unknown.²⁵

Zavegepant achieves the fastest absorption, with a T_max of 30 minutes, but has a shorter half-life (approximately 5 hours) than the other agents.^24-26 The T_max and C_max for ubrogepant may be delayed when administered with a high-fat meal.²⁴ All 3 drugs are primarily metabolized by CYP3A4 and excreted predominantly via feces.^24-26

Clinical Considerations for Use and Pharmacist Recommendations for Counseling and Monitoring

Refer to the Table for a comparison of key comparative drug characteristics associated with these medications.^13,24-26 Lasmiditan and the CGRP receptor antagonists are valuable alternatives for the acute treatment of migraine, particularly in patients who cannot tolerate or who may have contraindications to use of other abortive treatments for acute migraine. Monitoring should include efficacy (eg, reduction in migraine pain and associated symptoms) and occurrence of any AEs, especially in patients using other CNS depressants or hepatically metabolized medications.^13,24-26 A key clinical consideration for lasmiditan is its mechanism as a selective 5-HT_1F receptor agonist, which is associated with CNS effects, including dizziness and sedation. Patients should avoid driving or operating machinery for at least 8 hours post dose.¹³ Further, lasmiditan may be associated with the potential for misuse and abuse, based on effects of euphoria and hallucinations, warranting pharmacists' vigilance. Similar to other acute migraine treatments (eg, ergotamines, triptans), serotonin syndrome and medication overuse headache may occur.¹³ Counsel patients on these potentially serious AEs and avoid potential medication overuse headache by ensuring patients are not using these agents more than 10 days per month.¹³

The CGRP receptor antagonists do not cross the blood-brain barrier as readily and are generally better tolerated, with nausea and fatigue being the most reported AEs.^24-27 According to recent postmarketing findings, these medications may rarely be associated with vasoconstriction, necessitating pharmacist monitoring for new-onset or worsening of preexisting hypertension.^24-27,35 Rarely, cases of Raynaud phenomenon have been reported with the use of these medications.^24-27 Importantly, clinical trials suggest that the CGRP antagonists do not appear to be associated with medication-overuse headaches.³⁶ Pharmacists should recognize these warnings and precautions and be able to suggest that patients seek appropriate medical attention should they occur.^24-27

When selecting among these options, clinicians should consider individual patient comorbidities, potential for drug-drug interactions, hepatic function, and frequency of migraine attacks to avoid medication overuse. Additionally, rimegepant has dual utility, approved for both acute and preventive treatment, offering flexibility in therapeutic planning.²⁶

Conclusion

Lasmiditan and the CGRP antagonists represent medications approved for acute abortive treatment of migraine headache with novel mechanisms of action. Medications in these classes may be useful alternatives for those patients who cannot use triptans due to contraindications or who have not had success with triptans. Although direct comparison with standard treatments is difficult, medications in these classes may be less effective than triptans at a higher cost.³⁷ Pharmacists should consider formulary coverage along with patient characteristics and preferences in identifying an optimal treatment approach for this common medical condition.

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