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Oral atogepant therapy trims number of days with migraines, headaches

Journal
The New England Journal of Medicine
Reuters Health - 18/08/2021 - Twelve weeks of therapy with varying doses of AbbVie's experimental oral migraine drug prevented one or two attacks per month compared with placebo, according to results of the company-funded ADVANCE trial.

The 873 volunteers in the study were having a mean of 7.4 migraine days per month before treatment. Compared with placebo, the number of migraine days was 1.2 fewer with the smallest dose of the drug, atogepant, 1.4 days fewer at three times the smallest dose and 1.7 days fewer with six times the smallest dose (P<0.001 for all doses versus placebos).

Although longer and larger trials are needed, "oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks," Dr. Jessica Ailani of MedStar Georgetown University Hospital, in Washington D.C., an colleagues write in the New England Journal of Medicine.

The mean number of headache days per month was 9.3 at baseline. The number dropped by 1.4 days compared to placebo in the 10 mg group, 1.5 days in the 30 mg group and 1.7 days in the 60 mg group.

Treatment-related adverse events occurred in 23% receiving the lowest dose, 15% who were on the middle dose and 20% on the highest dose versus 9% on placebo.

The most significant side effects were constipation and nausea. The constipation rate was 0.5% with placebo but ranged from 6.9% to 7.7% with active treatment, depending on the drug dose. Nausea occurred in 1.8% who took placebo versus 4.4% to 6.1% with atogepant.

Only four volunteers - include two in the placebo group - experienced a serious adverse event. People who reported 15 or more headache days per month were excluded from the test.

The researchers say that while 29% of placebo recipients reported a reduction of at least 50% in the mean number of migraine days per month, as averaged over three months, the success rate by the metric ranged from 56% in the low-dose group to 61% among the high-dose recipients.

Migraines affect about 39 million people in the United States, according to the Migraine Research Foundation.

AbbVie released topline results from the ADVANCE study on July 29, 2020. The company said in March that it expects a decision from the U.S. Food and Drug Administration on its New Drug Application sometime during this quarter.

SOURCE: https://bit.ly/3CSZBas The New England Journal of Medicine, online August 18, 2021.

By Reuters Staff



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