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HEAD-TO-HEAD OPEN LABEL STUDY in chronic migraine DemonstrateS A more favorable tolerability profile FOR BOTOX® (onabotulinumtoxinA) WHEN COMPARED TO TOPAMAX® (topiramate) WITH fewer discontinuations Due to Adverse Events

Allergan
Posted on: 09 Sep 17

– Prospective, open label, head-to-head clinical trial data presented at 18th Congress of the International Headache Society in Vancouver, Canada –

 

– Findings of this study also demonstrate BOTOX® had a significantly higher efficacy profile than TOPAMAX®, based on achieving at least a 50% reduction in headache days

 

DUBLIN, IRELAND September 8, 2017 Allergan plc (NYSE:AGN) today announced new head-to-head data from an open label study in Chronic Migraine in 282 patients, demonstrating that BOTOX® (onabotulinumtoxinA) had a more favorable tolerability profile than TOPAMAX® (topiramate). Of patients randomized to receive topiramate, 50.7% of patients discontinued treatment due to adverse events, compared to 3.6% of patients randomized to receive onabotulinumtoxinA.1 Findings also show a significantly higher number of patients reported at least a 50% reduction in headache frequency when treated with onabotulinumtoxinA, compared to those treated with topiramate (40.0% vs 12.0%, p<0.001).1

These data, from the multi-center, prospective, open label FORWARD study, were presented for the first time today at the 18th Congress of the International Headache Society in Vancouver, Canada.

John F. Rothrock, MD, Professor and Vice-Chair of the Department of Neurology at The George Washington University School of Medicine & Health Science, comments: "These results are relevant for practicing clinicians, coming as they do from a study involving BOTOX® and TOPAMAX®, the latter a frequently prescribed therapy for migraine prevention. At least for the treatment of chronic migraine, this study demonstrates that BOTOX® is an important treatment option for the millions afflicted with this disorder." 

OnabotulinumtoxinA was generally well tolerated with 45.5% of patients reporting an adverse event (reported by more than 5% of any treatment group), the most common being sinusitis and neck pain – reported by 5.5% and 4.5% of patients, respectively.1 This compares with 76.8% of patients in the topiramate group, with paraesthesia, nausea and fatigue being the most common adverse events – reported by 31.0%, 13.4% and 13.4% of patients, respectively.1 Cognitive disorder was also reported in 12.7% of patients randomized to receive topiramate, compared to 0.5% of patients receiving onabotulinumtoxinA.1

The World Health Organization classifies migraine as being amongst the world’s most disabling conditions.2 Migraine is classified (by ICHD-3b) generally by attack frequency, with Chronic Migraine being a distinct neurological disease where people experience 15 or more headache days per month of which 8 or more are migraine days, for at least 3 months.3 Given the frequency of repeated attacks, Chronic Migraine is often debilitating with substantial individual, familial, economic and societal burdens.4,5

Allergan's Commitment to People with Migraine

Allergan is committed to advancing the science of migraine through ongoing research and clinical investment, while providing innovative treatment approaches, educational opportunities and support services that improve the lives of patients. Through our efforts, Allergan tirelessly pursues freedom from migraine in partnership with the entire migraine community.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 09/09/2017

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