Impact of Fremanezumab on the Number of Days With Use of Acute Headache Medications in Episodic Migraine (P4.106)

Objective: To evaluate efficacy of fremanezumab in patients with episodic migraine (EM) by assessing the change in use of acute headache medications. Background: Overuse of acute headache medications in people with EM can lead to worsening of headaches or transformation to chronic migraine. Fremanezumab (TEV-48125), a fully humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP), has proven efficacy in migraine prevention. Design/Methods: In this Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, eligible adult patients with prospectively confirmed EM (6–14 headache days and ≥4 migraine days per month) were randomized 1:1:1 to receive subcutaneous injections of fremanezumab monthly (225 mg at baseline, Weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, and placebo at Weeks 4 and 8), or placebo at each time point over a 12-week treatment period. The monthly numbers of days on which patients used either acute headache medications of any type or those specific to migraine (triptans and ergots) were evaluated as secondary and exploratory endpoints. Results: 875 patients were randomized (monthly, N=290; quarterly, N=291; placebo, N=294). Both fremanezumab regimens significantly reduced the monthly number of days with use of any acute medication (monthly: −3.0±0.22 days; quarterly: −2.9±0.22 days;) versus placebo (−1.6±0.21 days) during the 12-week treatment period (both, P P P P Conclusions: Fremanezumab reduces the need for acute headache and migraine-specific medication use in patients with EM. Study Supported by: This study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel. Disclosure: Dr. Brandes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory boards: Amgen, Lilly, Promius, Supernus; consulting for Amgen, Promius. Dr. Brandes has received research support from Amgen, Teva, Allergan, Colucid, Zotrip. Dr. Sakai has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Blankenbiller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Grozinski-Wolff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Aycardi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Bigal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals.