Evidence map›Paper›PMID 39501702›Full record

ArticleHeadache2025

Effects of multiple-dose administration of zavegepant nasal spray on the single-dose pharmacokinetics of ethinyl estradiol-levonorgestrel.

Rajinder Bhardwaj, Julie Collins, Jennifer Madonia, Kyle Matschke, Richard Bertz, Jing Liu

Abstract readClinical Trial, Phase I
In one paragraph

Article in Headache, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Clinical evaluation of zavegepant for the acute treatment of migraine.Journal of managed care & specialty pharmacy · 2025
    Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Rajinder BhardwajCertara USA, Princeton, New Jersey, USA.
Julie CollinsPfizer Inc., Groton, Connecticut, USA.
Jennifer MadoniaBiohaven Pharmaceuticals, New Haven, Connecticut, USA.
Kyle MatschkePfizer Inc., Collegeville, Pennsylvania, USA.
Richard BertzBiohaven Pharmaceuticals, New Haven, Connecticut, USA.
Jing LiuPfizer Inc., New York, New York, USA.

Funding

Biohaven Pharmaceuticals, Inc.Pfizer Inc.
6 · The paper itself

Abstract

objectiveThe potential for drug-drug interaction of multiple-dose intranasal zavegepant on the single-dose oral contraceptive ethinyl estradiol and levonorgestrel (EE-LNG) was evaluated.

backgroundZavegepant (as a nasal spray) is a calcitonin gene-related peptide receptor antagonist approved in the United States for treatment of acute migraine in adults.

methodsThis single-center, Phase 1, open-label, fixed-sequence study included healthy, nonsmoking females (18-45 years old). In treatment Period 1, a single oral dose of EE-LNG 0.02-0.10 mg was administered on Day 1. In treatment Period 2, intranasal zavegepant (20 mg daily; 10 mg per nostril separated by 1 h) was administered on Days 1-5; 1 oral dose of EE-LNG 0.02-0.10 mg was administered immediately after first 10 mg intranasal zavegepant dose on Day 2. Blood samples for EE-LNG concentrations were collected on Day 1, treatment Period 1, and Day 2, treatment Period 2, and zavegepant concentrations on Day 2, treatment Period 2. Noncompartmental pharmacokinetic parameters included maximum observed concentration (C

resultsStatistical comparisons of pharmacokinetic exposure parameters after co-administration of zavegepant and EE-LNG versus EE-LNG alone showed small, but statistically insignificant, changes in either EE or LNG exposure. EE comparison ratios (90% confidence intervals [CIs]) were 109.9% (105.3%, 114.8%) for AUC

conclusionCo-administration of zavegepant nasal spray with a single dose of an oral contraceptive resulted in no clinically meaningful changes (<12% increase) in EE-LNG exposure.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsEthinyl EstradiolLevonorgestrelAdministration, IntranasalAdolescentAdultDose-Response Relationship, DrugDrug CombinationsDrug InteractionsFemaleHumansMiddle AgedNasal SpraysNorprogesteronesYoung AdultCalcitonin Gene-Related Peptide Receptor AntagonistsDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationLevonorgestrelNasal SpraysNorprogesteronesST 1435calcitonin gene‐related peptide receptor antagonistdrug–drug interactionethinyl estradiol‐levonorgestrelnasal sprayoral contraceptivezavegepant

Identifiers

PMID39501702
PMCPMC11725995

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.