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OnabotulinumtoxinA in Chronic Migraine: A Profile of Its Use

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posted on 17.12.2020, 02:09 by James Frampton

Acknowledgements During the peer review process, the manufacturer of onabotulinumtoxinA was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest James Frampton is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable


Additional information about this Adis Drug Review can be found here


Abstract

OnabotulinumtoxinA (Botox®; a formulation of botulinum toxin type A (BoNT/A)] is indicated for the prevention of headaches in adults with chronic migraine (CM) in numerous countries, including those of Europe. In clinical trials, intramuscular administration of BoNT/A (155–195 units at 12-week intervals) to patients with CM was generally well tolerated and associated with sustained and clinically meaningful improvements in multiple assessments of headache symptoms, headache-related impact and/or disability and migraine-specific health-related quality of life over a period of 1 year (in the pivotal PREEMPT 1 and 2 studies) and 2 years (in the phase IV COMPEL study). The efficacy and safety of BoNT/A therapy have been confirmed in a number of large, prospective, real-world studies conducted in Europe, including the 2-year REPOSE study. Intramuscular BoNT/A has also demonstrated greater clinical utility than the oral prophylactic medication topiramate in a clinical practice setting (FORWARD study).

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