BACKGROUND: Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed 
against calcitonin-gene-related peptide (CGRP), a validated target for migraine 
preventive therapy. In two previous phase 2 studies, fremanezumab administered 
once every 28 days for 12 weeks was found to be effective and safe as a 
preventive treatment for patients suffering from episodic migraine (EM) and 
chronic migraine (CM).
OBJECTIVE: To evaluate the efficacy and safety of fremanezumab as an add-on 
preventive therapy in individuals with EM and CM who are on stable doses of 
preventive migraine medications.
METHODS: Two randomized placebo-controlled studies tested once-monthly 
subcutaneous injections of various dosing regimens of fremanezumab versus 
placebo in EM and CM. Headache information was captured daily using an 
electronic headache diary. For these post hoc analyses, data were pooled from 
patients who were on stable preventive medications and taking fremanezumab doses 
of 225 mg or 675/225 mg, or placebo.
RESULTS: The sample consisted of 133 patients, (67 fremanezumab and 66 placebo). 
Total reduction in migraine days for the duration of the study was 12.4 for 
fremanezumab and 7.4 for placebo (P = .0321). There were also decreases in 
moderate/severe headache days (12.5 vs 7.1, P = .0058), and days using acute 
medication for headaches relative to placebo (11.6 vs 7.5, P = .0414). Treatment 
emergent adverse events were generally mild and transient, and no serious 
adverse events were considered to be treatment-related by the site 
investigators.
CONCLUSIONS: The findings from these post hoc analyses suggest that fremanezumab 
is a safe and effective add-on treatment for migraine patients being 
concomitantly treated with other migraine preventive medications. Trials are 
registered at Clinicaltrials.gov NCT02025556 and NCT02021773.