Article
Migraine Treatments and the FDA: Test Your IQ
Author(s):
Do you know about these handheld noninvasive devices for acute migraines and for migraine prophylaxis? About CGRPs anticipating FDA approval?
Question 1
Answer and Question 2 on Next Page »
Answer A.gammaCore®
Discussion
In January 2018, gammaCore® became the first handheld noninvasive vagus nerve stimulator to gain FDA approval for the acute treatment of migraine.1
The approval expanded the indication for gammaCore®, which was originally approved for treating episodic migraine in April 2017. GammaCore® is expected to be commercially available in the second quarter of 2018. Aspire SR, SenTivam, and RNS Stimulator are implantable vagus nerve stimulators used to manage epilepsy.
Question 2
Answer and Question 3 on Next Page »
Answer D. Fremanezumab and erenumab
Discussion
Both Erenumab and fremanezumab are monoclonal antibodies that inhibit the calcitonin gene-related peptide (CGRP) receptor, thought to play a causal role in migraine development. The FDA accepted for review the biologics license application (BLA) for erenumab in July 2017.2
The BLA for fremanezumab was accepted for review in December 2017, and approval is expected in 2018. Omalizumab is a monoclonal antibody used to treat asthma.3
Question 3
Answer B. SpringTMS®
Discussion
In September 2017, SpringTMS® became the first handheld, noninvasive transcranial magnetic stimulator to gain FDA approval for the acute treatment of migraine and for migraine prevention.4
The device is applied to the occiput and delivers electrical pulses with the push of a button. Neurostar and MagVita are office-based TMS treatments used to treat major depressive disorder.
References:
1. Electrocore LLC. gammaCore® Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients. January 29, 2018. https://www.prnewswire.com/news-releases/gammacore-receives-fda-clearance-for-the-acute-treatment-of-pain-associated-with-migraine-headache-in-adult-patients-300589314.html. Accessed April 30, 2018.
2. Amgen. FDA Accepts Biologics License Application For Aimovig™(erenumab). https://www.amgen.com/media/news-releases/2017/07/fda-accepts-biologics-license-application-for-aimovig-erenumab. Accessed April 30, 2018.
3. Teva Pharmaceutical Industries, Ltd. FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program. http://www.tevapharm.com/news/fda_accepts_biologics_license_application_for_fremanezumab_with_priority_review_for_prevention_of_migraine_and_grants_fast_track_designation_for_cluster_headache_development_program_12_17.aspx. Accessed April 30, 2018.
4. eNeura, Inc. eNeura, Inc. Receives FDA Clearance for Use of SpringTMS® for Migraine Prevention SpringTMS is the only product available to patients in the United States for both acute treatment of migraine and migraine prevention. Sept 7, 2017. https://www.prnewswire.com/news-releases/eneura-inc-receives-fda-clearance-for-use-of-springtms-for-migraine-prevention-300515593.html. Accessed April 30, 2018.
