New Entries into the Migraine Market: 2018-2021

Abstract

Migraine is a chronic condition of recurring headaches, often severe and disabling, not in the least because of the associated gastrointestinal symptoms. The focus of its treatment is pharmacological, which we traditionally divide into abortive or acute and preventive or prophylactic. In the 4-year period, 2018-2021, the United States (US) Food and Drug Administration (FDA) approved twelve new entries into the migraine market, six for abortive treatment and six for preventive treatment, including one for both. Three of them are reformulations of already marketed medications, four are CGRP antibodies, three are small-molecule CGRP-receptor antagonists or gepants, and one is a serotonin-1F receptor agonist or ditan. In this paper, we review the twelve new migraine entries in light of the abortive and preventive migraine medications marketed prior to 2018. We present the efficacy of four of the new entries for migraine abortion – the FDA approved the remaining two based on comparable bioavailability – and of all six of the new entries for migraine prevention, focusing on 2-hour pain-free and 50%-responder rates, respectively. We conclude that preventively we have made progress if only because of the (much) better tolerability of the CGRP antibodies and gepants, in comparison to the traditional oral preventive migraine medications. In terms of efficacy, we probably have made progress as well although supported by only one randomized, double-blinded, head-to-head comparative trial. Abortively, the three new chemical entities in the classes of gepants and ditans lack vasoconstrictor activity and, hence, we can prescribe them where the ergots and triptans are contraindicated. This is a step ahead in safety while tolerability and efficacy seem similar to that of the triptans, the mainstay in abortive migraine treatment.