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Alder, Allergan report success in developing migraine treatments
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Two pharmaceutical companies recently reported positive results in trials involving therapies for migraines, a condition that according to the Migraine Research Foundation is the third-most common illness in the world.
Alder Biopharmaceuticals’ IV drug eptinezumab showed promise in two trials, Richard Lipton, MD, director of the Montefiore Headache Center, Albert Einstein College of Medicine, told Healio Family Medicine.
In the first trial, 70.7% of trial participants receiving the drug had an average of 50% reduction or more of migraine days per month from baseline vs. 58.7% of patients receiving placebo following the third and fourth quarterly infusions at 100 mg and 300 dose mg levels. In addition, 51.5% of trial participants had an average of 75% reduction or more of monthly migraine days from baseline vs. 38.7% of trial participants receiving placebo.
Lipton added that another trial showed eptinezumab improved quality-of-life outcomes in patients with episodic migraine and increased migraine-free intervals (up to 32.5 days). Those trial participants with a 75% or greater response had an eightfold increase in migraine-free days and “more meaningful improvements” in physical function and bodily pain.
“If approved, eptinezumab will be the first and only [calcitonin gene-related peptide] inhibitor delivered by quarterly infusion, which results in 100% bioavailability. In the clinical program, eptinezumab has consistently demonstrated rapid, effective and sustained migraine prevention in both chronic and episodic migraine,” he said in an interview.
The studies’ findings were presented at the American Academy of Neurology annual meeting. Alder Biopharmaceuticals intends to submit its Biologics License Application to the FDA for eptinezumab during the second half of this year.
Allergan said a phase 3 trial assessing the tolerability, safety and efficacy of 25 mg and 50 mg oral doses of ubrogepant vs. placebo in single migraine attack in adults produced positive results.
According to a press release, both doses showed improvement in trial participants obtaining pain freedom at 2 hours after the first dose vs. trial participants receiving placebo (25 mg vs. placebo, P = .0285; 50 mg vs. placebo, P = .0129). Both doses also showed greater percentages of patients receiving ubrogepant had none of the “most bothersome migraine-associated symptom” at 2 hours after the initial dose vs. placebo patients (25 mg vs placebo, P = .0711; 50 mg vs. placebo, P = .0129).
In addition, trial participants receiving the 50-mg dose also showed a statistically significantly greater percentage of patients achieving pain relief at 2 hours, sustained pain relief from 2 to 24 hours, and maintained freedom from pain from 2 to 24 hours after the first dose vs. placebo (P for trend = .0129). These same participants had a statistically significantly greater percentage of patients achieving absence of phonophobia (P = .0440) and photophobia (P = .0167) at 2 hours after the first dose vs. placebo. The 25-mg dose vs. placebo did not show statistical significance in these endpoints, the press release stated.
The findings build on a previous trial that also had positive outcomes, a company representative said.
“The consistency in response between both [trials] provides further evidence that ubrogepant, an oral calcitonin gene-related peptide receptor antagonist, offers a promising opportunity for the acute treatment of migraine,” David Nicholson, Allergan’s chief research and development officer said in the press release.
The company expects to file a New Drug Application with the FDA for the drug in 2019. – by Janel Miller
Reference: Migraineresearchfoundation.org. About migraine. http://migraineresearchfoundation.org/about-migraine/migraine-facts/ Accessed May 2, 2018
Disclosure: Nicholson is an employee of Allergan. Healio Family Medicine was unable to determine relevant financial disclosures for Lipton prior to publication.