Zavegepant: First Approval

Dhillon, Sohita

doi:10.1007/s40265-023-01885-6

Cited by 15 publications

(12 citation statements)

References 9 publications

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“…Additionally, various CGRP-targeting drugs are thought to increase the risk of alopecia ( 76 ). As these drugs have been approved for marketing only in recent years [especially Zavegepant, which was approved this year ( 77 )], there is currently a lack of comprehensive reporting on drug-related side effects. The long-term effectiveness and safety of these drugs require further investigation.…”

Section: Discussionmentioning

confidence: 99%

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Wei,

Lv,

Yang

et al. 2024

Front. Neurol.

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BackgroundMigraine imposes a substantial global burden, impacting patients and society. Pharmacotherapy, as a primary treatment, entails specific adverse reactions. Emphasizing these reactions is pivotal for improving treatment strategies and enhancing patients’ well-being. Thus, we conducted a comprehensive bibliometric and visual analysis of relevant literature.MethodologyWe conducted a comprehensive search on the Science Citation Index Expanded within the Web of Science, restricting the literature for analysis based on criteria such as document type, publication date, and language. Subsequently, we utilized various analytical tools, including VOSviewer, Scimago Graphica, the R package ‘bibliometrix’, CiteSpace, and Excel programs, for a meticulous examination and systematic organization of data concerning journals, authors, countries/regions, institutions, keywords, and references.ResultsBy August 31, 2023, the literature was distributed across 379 journals worldwide, authored by 4,235 individuals from 1726 institutions. It featured 2,363 keywords and 38,412 references. ‘HEADACHE’ led in publication count, with ‘SILBERSTEIN S’ as the most prolific author. The United States ranked highest in publication volume, with ‘UNIV COPENHAGEN’ leading among institutions.ConclusionOur research findings indicate that researchers in the field continue to maintain a focus on the calcitonin gene-related peptide (CGRP) system and explore diverse mechanisms for drug development through the application of novel biotechnological approaches. Furthermore, it is imperative to enhance the assessment of clinical trial outcomes, consistently monitor the efficacy and safety of prominent drugs such as Erenumab and Fremanezumab. There is a need for further evaluation of acute and preventive treatments tailored to different populations and varying types of migraine.

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Section: Discussionmentioning

confidence: 99%

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Wei,

Lv,

Yang

et al. 2024

Front. Neurol.

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“…In March 2023, zavegepant nasal spray was approved in the United States for the acute treatment of migraine in adults. 51 In a phase III study of zavegepant, 1269 patients with migraine were randomly assigned at a ratio of 1:1 to either a group receiving 10 mg of zavegepant nasal spray or a placebo group. Patients with CM were excluded from the trial.…”

Section: Zavegepantmentioning

confidence: 99%

“…The results indicated that the treatment dose of zavegepant resulted in a clear improvement in the pain-free rate after 2 hours, with the alleviation of other migraine symptoms. 51,52 Zavegepant demonstrated obvious clinical benefits, with pain relief after 15 minutes and a return to normal function after 30 minutes of administration. In both treatment groups, the most common AEs were dysgeusia, nasal discomfort, and nausea, with no signs of hepatotoxicity.…”

Section: Zavegepantmentioning

confidence: 99%

Update on gepants for the treatment of chronic migraine

Aoh,

Hou,

Yang

et al. 2024

Journal of the Chinese Medical Association

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Chronic migraine (CM) is a profoundly debilitating condition that has detrimental clinical and social outcomes. Over the past two decades, novel small-molecule calcitonin gene related peptide (CGRP) receptor antagonists, known as gepants, and CGRP monoclonal antibodies (mAbs) have been developed, ushering in a new era of migraine-specific treatment. In this review, we discuss the literature investigating the role of gepants for the treatment of CM. Numerous completed and ongoing clinical studies have conclusively demonstrated the safety, tolerability, and efficacy of several gepants for the acute treatment of migraine. However, preventive trials involving gepants have focused on patients with episodic migraine, with atogepant being the only gepant approved for CM prevention by the US Food and Drug Administration at the time of writing. Although some preliminary positive results have been reported, further research is still required to achieve additional advancements in the future. In summary, the effectiveness of gepants for treating individuals with CM are highly expected. This review highlights the development and current progress of gepants for the treatment of CM, focusing both on their role as acute abortive agents and preventive measures and on their concomitant use with other antimigraine medications, such as CGRP mAbs or triptans.

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“…The release of calcitonin gene-related peptide (CGRP) is involved in the migraine pathophysiology and monoclonal antibodies and small molecule CGRP receptor antagonists have been approved against this disease (Nisar et al 2023 ). Zavegepant is a third generation, highly potent, selective, competitive, intranasally administered CGRP receptor antagonist that is approved for the acute, but not for the prophylactic treatment, of migraine (Dhillon 2023c ; Larik et al 2023 ). Intranasal zavegepant may benefit patients with migraine for whom oral medications are ineffective, slow-acting, or intolerable due to vomiting (Lipton et al 2023 ).…”

Section: Neurologymentioning

confidence: 99%

“…Intranasal zavegepant may benefit patients with migraine for whom oral medications are ineffective, slow-acting, or intolerable due to vomiting (Lipton et al 2023 ). The most frequent AE are taste disorders, nausea-vomiting, and nasal discomfort (Dhillon 2023c ).…”

Section: Neurologymentioning

confidence: 99%

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023

Kayki-Mutlu,

Aksoyalp,

Wojnowski

et al. 2024

Naunyn-Schmiedeberg's Arch Pharmacol

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With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition (“first-in-indication”), first drug using a novel molecular mechanism (“first-in-class”), and “next-in-class,” i.e., a drug using an already exploited molecular mechanism. We identify four (7%) “first-in-indication,” 22 (36%) “first-in-class,” and 35 (57%) “next-in-class” drugs. By treatment area, rare diseases (54%) and cancer drugs (23%) were once again the most prevalent (and partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics). 2023 marks the approval of a first therapy based on CRISPR/Cas9 gene editing.

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Zavegepant: First Approval

Cited by 15 publications

References 9 publications

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Update on gepants for the treatment of chronic migraine

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023

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