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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: 08 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.

 

### ENDS ###

 

 

About FORWARD

This randomized, open label head-to-head study evaluated BOTOX® (onabotulinumtoxinA) and TOPAMAX® (topiramate) as preventive treatment options for Chronic Migraine.1 During the randomization treatment period, 282 patients received either intramuscular injections of BOTOX® 155 U approximately every 12 weeks for up to 3 treatment sessions or between 50-100 mg/day of oral TOPAMAX® administered daily up to Week 36.1 Patients who discontinue TOPAMAX® at any time up to or including Week 36, transitioned to receive treatment with BOTOX® for the remainder of the study.1 The primary efficacy endpoint was analyzed as a responder versus non-responder analyses using logistic regression and adjusting for the baseline number of headache days. Worst case imputation method was used to account for differences in treatment discontinuation rates whereby missing values were replaced with the baseline value (i.e., the frequency of headache days during the 28-day run-in period) for primary and secondary efficacy endpoints. Further analyses will evaluate the outcomes for those patients who stayed on treatment as randomized and will evaluate the efficacy of those who were randomized to TOPAMAX® and crossed over to BOTOX®.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

 

References

1 Rothrock, J et al. A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of OnabotulinumtoxinA and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study. Presented at the 18th Congress of the International Headache Society, 7-10 September 2017. PO-01-185

2 http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed September 01, 2017.

3 https://www.ichd-3.org/1-migraine/1-3-chronic-migraine/. Accessed September 01, 2017

4 Manack AN, Buse DC, Lipton RB. Chronic migraine: epidemiology and disease burden. Curr Pain Headache Rep. 2011;15(1):70-78.

5 Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO Study. Mayo Clin Proc. 2016;91(5):596-611.

For more information:
www.allergan.com/home

Editor's Details

Sophia James
www.allergan.com/home
na
James_Sophia@Allergan.com

Last updated on: 08/09/2017

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