Allergan plc / MAP Pharmaceuticals Inc.

Acute Migraine in Adults

Disease Overview

Migraine is a recurrent neurovascular headache disorder marked by throbbing pain, photophobia, phonophobia, nausea, and sometimes aura. It affects roughly 30 million Americans, disproportionately women, and ranks among the leading causes of disability worldwide. Acute therapy targets fast pain relief and elimination of associated symptoms, complemented by preventive therapy for high-frequency or chronic migraine.

Competitive Landscape

In early 2013 acute migraine therapy was anchored by oral triptans (sumatriptan / Imitrex, rizatriptan / Maxalt, and follow-ons), with limited differentiation as most had gone generic. For triptan-refractory patients or those needing fast non-oral delivery, Valeant's Migranal (DHE nasal spray) and injectable DHE were the main alternatives. Levadex (orally inhaled dihydroergotamine) was MAP Pharmaceuticals' lead asset — a reformulated DHE designed for fast pulmonary absorption with lower nausea than IV/IM DHE. The pivotal FREEDOM-301 trial met all four primary endpoints. Allergan and MAP had a January 2011 co-promotion deal ($60M upfront + up to $97M in milestones) for neurology/pain physicians; the January 2013 acquisition at $25/share (60% premium, ~$958M) consolidated full economics ahead of the April 15, 2013 PDUFA date. The deal also gave Allergan inhalation platform IP. Levadex was ultimately rejected by FDA in March 2012 on CMC issues, then again in April 2013 (Complete Response Letter on CMC and third-party manufacturing inspection observations) — no clinical safety/efficacy concerns. The franchise was eventually shelved, and CGRP-targeted classes (Aimovig, Ubrelvy, Nurtec) and STS101 nasal-powder DHE later reshaped the migraine market. Source: https://www.genengnews.com/news/allergan-grows-migraine-portfolio-with-958m-map-purchase/