Ajovy significantly reduces depressive symptoms of and migraine days in patients with migraine and depression: Phase 4 study

UNITE is a double-blind, randomised, placebo-controlled, Phase 4 study sponsored by Teva Pharmaceutical investigating the safety, efficacy, and impact of fremanezumab on patients with major depressive disorder and migraine.

The key findings of the trial are as follows:

• Patients in the study treated with fremanezumab experienced a significant reduction in Monthly Migraine Days (MMD) compared to patients on placebo, with a reduction in MMD of –5.1 vs –2.9 for fremanezumab vs placebo.
• On the Hamilton Rating Scale for Depression, the mean score change at week 12 was –6.7 for those treated with fremanezumab and –5.4 for placebo. On the Patient Health Questionnaire-9, the mean changes were –7.8 and –6.3, respectively.
• A significantly higher number of patients (33%), receiving fremanezumab achieved ≥50% reduction in MMD compared to placebo (13%) during the 12-week double-blind period, with a sustained reduction over the longer-term.
• At week 12, participants’ mean change in Headache Impact Test score was –8.8 and –5.2 for fremanezumab and placebo, respectively, and the mean change in Clinical Global Impression-Severity score was –1.1 and –0.8

The results suggest fremanezumab “has the potential to reduce the symptoms and cumulative burden of migraine and associated depression,” the company said in the release.