Log In

Forgot Password?

OR

Not a member? Continue as a nonmember.

Become a Member

By becoming a member of the AAN, you can receive exclusive information to help you at every stage of your career. Benefits include:

Join Now See All Benefits

Loading... please wait

Abstract Details

Impact of Fremanezumab on Migraine-associated Symptoms in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-007
Non-headache migraine-related symptoms may be particularly disabling and are often rated the most bothersome symptom of migraine. The efficacy and tolerability of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and has been approved for the preventive treatment of migraine, have been shown for patients failing multiple prior migraine preventive medication classes in the double-blind period of the phase 3b FOCUS study. 
To assess changes in migraine-related symptoms (nausea/vomiting and photophobia/phonophobia) with fremanezumab treatment during up to 6 months in patients with episodic and chronic migraine (EM and CM) and documented inadequate response to 2-4 classes of migraine preventive medications.
The FOCUS study included both a 12-week, double-blind, placebo-controlled treatment period and 12-week, open-label treatment period. Patients were initially randomized (1:1:1) to quarterly fremanezumab (Month 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Month 1/2/3: 675mg[CM],225mg[EM]/225mg/225mg), or matched monthly placebo for a 12-week, double-blind period. All patients completing double-blind treatment entered the open-label period and received three monthly doses of fremanezumab (225mg). Changes in monthly days with nausea or vomiting and photophobia and phonophobia from baseline (assessed during 28-day run-in period before first double-blind dose) were evaluated during the open-label period and summarized by double-blind randomization group.
Of 838 patients randomized, 807 completed double-blind treatment and entered the open-label period. Reductions from baseline in monthly average days with nausea or vomiting during the 12-week open-label treatment period were observed in the placebo (−2.3[4.55]), quarterly fremanezumab (−3.1[4.46]), and monthly fremanezumab (−3.0[4.44]) groups. Reductions from baseline during the open-label treatment period were also observed in monthly average days with photophobia and phonophobia (−3.2[5.27], −3.4[5.27], and −4.0[5.19], respectively). 
Reductions in migraine-related symptoms were observed with up to 6 months of fremanezumab treatment in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive medications.
Authors/Disclosures
Laszlo Mechtler, MD, FAAN, FASN (Dent Neurologic Institute)
PRESENTER
Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Jushi Inc. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Mechtler has received stock or an ownership interest from Jushi Co.. The institution of Dr. Mechtler has received research support from The Harry Dent Family Foundation, Inc. The institution of Dr. Mechtler has received research support from Amgen/Novartis. The institution of Dr. Mechtler has received research support from Alder/ Lundbeck. The institution of Dr. Mechtler has received research support from Abbvie/Allergan. The institution of Dr. Mechtler has received research support from Miles for Migraine. The institution of Dr. Mechtler has received research support from American Migraine Foundation. The institution of Dr. Mechtler has received research support from Charlotte's Web.
Xiaoping Ning (Teva pharmaceuticals) Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
Joshua M. Cohen, MD No disclosure on file
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Ronghua Yang, PhD (Teva Pharmaceutical) No disclosure on file