Novel Drug May Ease Chronic Migraine

Teva Pharmaceutical Industries’ investigational drug designed to prevent chronic migraines recently demonstrated positive results in a phase 2 study.

The study evaluated the efficacy, safety, and tolerability of 2 doses of subcutaneous TEV-48125 for 3 months. The research team found that patients treated with the investigational drug experienced a significant and clinically relevant reduction in the number of monthly cumulative headache hours, as well as the number of headache days of at least moderate severity, compared with placebo.

“For the first time in chronic migraine, there is clinical data on the positive role of calcitonin gene-related peptide (CGRP) signaling disruption using a monoclonal antibody,” said Marcelo E. Bigal, Teva’s Head of Global Clinical Development for Migraine and Headaches, in a press release.

Adverse events experienced by trial participants treated with TEV-48125 were comparable to those reported by placebo recipients, with only mild, transient injection site discomfort and redness more frequently reported in the former group.

Use of TEV-48125 was not associated with any serious treatment-related adverse event.

“Chronic migraine is a challenging, complex, and highly debilitating condition that desperately needs effective new treatment options,” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. “These results in support of TEV-48125 take us a step closer to realizing the potential of the anti-CGRP ligand-based approach for millions of women and men who suffer from chronic migraine.”

Teva said it will disclose the full results of the study at a forthcoming meeting.