Teva's anti-migraine drug TEV-48125 achieves primary and secondary endpoints at Phase IIb

24 March 2015

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) says that its investigational drug TEV-48125 achieved the primary and secondary endpoints of a Phase IIb study in episodic migraine.

TEV-48125 is an anti-calcitonin gene-related peptide monoclonal antibody being investigated for the prevention of episodic migraine. The HFEM study examined 297 patients with high-frequency episodic migraine, which is characterized by eight to 14 days of headache per month. Patients were randomized to once-monthly treatment with one of two doses of subcutaneous TEV-48125 or placebo over a three-month period. Initial analysis of the top-line results illustrated that both doses of TEV-48125 were associated with significant reductions in mean monthly migraine days and monthly headache days relative to baseline, compared to placebo.

Teva also said that TEV-48125 was linked to meaningful separation for the primary and secondary endpoints at all months of treatment in both the current study and a previous trial of patients with chronic migraine.

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