Clinical Data Presented at American Headache Society Meeting Shows Promise of New Treatments for Migraine Prevention

Research Highlights Prevention as well as Alleviation of Symptoms

SAN DIEGO, CA (June 9, 2016) – Clinical data presented this week at the 58th Annual Scientific Meeting of the American Headache Society calls attention to the promise of new treatments in development for migraine prevention as well as some that may help to alleviate symptoms of the acute attack. The meeting draws about 1,000 headache and migraine researchers and treatment specialists from around the world to hear the latest scientific and clinical information on headache and migraine. This year’s program, “Take a Closer Look…At Migraine,” is four days of scientific presentations on the latest and most up-to-date research in all aspects of migraine and related disorders.

Researchers at Montefiore Medical Center and Albert Einstein College of Medicine conducted a randomized, placebo controlled, double-blind trial of the efficacy of ubrogepant in treating a single migraine attack. Patients who received the study medication reported a reduction in headache severity from severe or moderate to mild or none within two hours. Ubrogepant is free of known cardiovascular risk and may provide an important treatment option for individuals who suffer from cardiovascular disease. This trial supports ubrogepant’s effectiveness and provides further evidence that CGRP receptor antagonists are viable options for the acute treatment of migraine.

“There is tremendous excitement around this innovative migraine treatment.” said Richard B. Lipton, M.D., study author and director of Montefiore Headache Center and vice chair of neurology, as well as the Edwin S. Lowe Chair in Neurology, Albert Einstein College of Medicine. “This new treatment may address a currently unmet need in the U.S. by providing a migraine treatment option to individuals with cardiovascular disease.”

For the preventive treatment of migraine a dose-ranging study, conducted by Eli Lilly and Company, initially reported top line results that at least one dose (120 mg) for patient trials of galcanezumab (LY2951742; an anti-CGRP antibody) resulted in a reduction of the number of migraine headache days experienced per month. Final results are now reported. Patients were treated with a once per month injection for a three-month period. At the end of the trial period, researchers compared the patient’s reported migraine headache days compared to their pre-treatment baseline and the two highest doses (120 and 300 mg) of galcanezumab were efficacious in patients with migraine.

“By offering a novel mechanism in monthly injections verses daily medication, galcanezumab provides a new and different treatment option for migraine sufferers to consider.” said Tina Oakes, Principal Research Scientist. “It relieves a burden for migraine sufferers by both reducing the number of migraine headache days experienced and eliminating the necessity of daily medication.”

Alder BioPharmaceuticals presented Phase 2b trial data showing that a single dose of ALD403, another anti-CGRP monoclonal antibody, acted rapidly to prevent migraine for up to three months in trial participants. The trial evaluated patients with chronic migraine, a severe form of the disease, ALD403 significantly reduced migraines by 75 percent in up to 33 percent of patients over the entire 12-week study period after a single dose and met both primary and secondary efficacy endpoints.

“A 75 percent reduction in migraine days for these patients means a reduction of 12 or more migraine days each month,” said Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine, at Alder. “This equates to giving patients roughly two weeks of their lives back every month after a single administration of ALD403, a substantial improvement that can transform the lives of these severely afflicted patients.”

Even on headache free days, migraine sufferers may experience a variety of symptoms contributing to their overall migraine disability burden. Researchers at the Mayo Clinic Arizona set out to evaluate whether a CGRP monoclonal antibody, TEV-48125, could provide benefit in  treating non-headache symptoms of migraine as there is little evidence that currently available medication is effective against these symptoms.

A post-hoc analysis of wellness in patients with Episodic Migraine and Chronic Migraine was conducted as part of the Phase 2b trials of TEV-48125. Data regarding patient-reported wellness was collected on headache free days and included the ability to work/study normally, no time spent working more slowly or taking longer to complete tasks, no difficulty concentrating on what needed to be done, no time feeling very tired/asleep/drained, performing household activities normally, being very engaged with partner’s or children’s activities, and being very interested in doing daily activities. The post-hoc analysis found that TEV-48125 appears to be effective in improving patients’  wellness on headache-free days as patients with episodic migraine receiving  TEV-48125 (225 mg or 675 mg) versus placebo reported more well days as did patients with chronic migraine receiving the 900mg dose of TEV-48125 versus placebo..

“Migraine is not just a headache disorder, there are a variety of symptoms stemming from migraine that impair a sufferers overall wellness.” said Juliana VanderPluym, Pediatric Neurologist, Fellow in Headache Medicine, Mayo Clinic Arizona. “It’s critical that we begin to refocus our perspective on migraine to help relieve the burden on sufferers.”

ABOUT THE AMERICAN HEADACHE SOCIETY
The American Headache Society (AHS) is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society’s objectives are to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals and the public and encouraging scientific research are the primary functions of this organization. AHS activities include an annual scientific meeting, a comprehensive headache symposium, regional symposia for neurologists and family practice physicians, and publication of the journal Headache. (www.americanheadachesociety.org)

ABOUT THE AMERICAN MIGRAINE FOUNDATION

The American Migraine Foundation is a non-profit foundation supported by the American Headache Society and generous donors dedicated to the advancement of migraine research. Its mission is to support innovative research and education that will lead to improvement in the lives of those who suffer from migraine and other disabling headaches. Information about migraine and related disorders can be found at www.americanmigrainefoundation.org