FDA Approves New Migraine Treatments

FDA Approves New Migraine Treatments
Released: 12/30/2019   By: Heidi Dufrene, PharmD

Two new medications for the treatment of acute migraine with or without aura in adults were approved by the U.S. Food and Drug Administration (FDA) — Ubrelvy (ubrogepant) and Reyvow (lasmiditan). These new medications are not indicated for the prevention of migraine headaches.

Ubrelvy (ubrogepant) is the first oral medication in its class, calcitonin gene-related peptide receptor antagonists (CGRP).  Approval for Ubrelvy was granted to Allergan USA, Inc. Other CGRP-related medications on the market are monoclonal antibodies which must be injected by the user and are used as preventative therapy. These include medications such as Emgality, Aimovig, and Ajovy.  The Official Disability Guidelines (ODG) list the injectable CGRP medications as not recommended for first or second line therapies for preventative migraine treatment.

Reyvow (lasmiditan)is the first medication in a new drug class for the acute treatment of migraine headaches.  Approval was granted to Eli Lilly and Company, whom states that Reyvow has a unique mechanism of action and is the first and only FDA-approved 1F serotonin receptor agonist.

Carlisle Medical will continue to monitor the development and release of Ubrelvy and Reyvow. Pricing for these medications is not yet available and their anticipated release is in the first quarter of 2020. Current treatments for acute migraine headaches include medications such as non-steroidal anti-inflammatory drugs (NSAIDS) and triptans such as Imitrex (sumatriptan).