A machine generated summary based on the work of Seng, Elizabeth K.; Rains, Jeanetta A.; Nicholson, Robert A.; Lipton, Richard B. 2015  in Current Pain and Headache Reports.

Ubrogepant: First Approval

DOI: https://doi.org/10.1007/s40265-020-01264-5

Abstract-Summary This article summarizes the milestones in the development of ubrogepant lead- ing to its first global approval for the acute treatment of migraine (± aura) in adults.

Introduction Extensive evidence supports the important role that CGRP plays in migraine patho- physiology, making CGRP and its receptors a novel therapeutic target for the treat- ment of migraine.

The recent development of agents that target CGRP and its receptors represent an

important advance in the management paradigm for migraine [33–35].

Ubrogepant (Ubrelvy™), a highly potent, orally administered small molecule, is a CGRP receptor antagonist being developed by Allergan under license from Merck & Co., for the acute treatment of migraine [36].

It is the first drug in the class of oral CRGP antagonists approved for the acute

treatment of migraine [37].

In July 2015, Merck & Co. entered into a licensing agreement with Allergan to divest the worldwide rights of small molecule CGRP receptor antagonists, atoge- pant and ubrogepant.

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4 Treatment

Scientific Summary In pivotal randomized, double-blind, multicentre, phase III trials (ACHIEVE I [38] and II [39]) in adults with moderate to severe migraine, recommended doses of ubrogepant (50 or 100 mg) were significantly more effective than placebo for the proportion of patients achieving the co-primary endpoints of freedom from pain 2 h after the initial dose and the absence of the most bothersome symptom (MBS; patient-specified MBS out of photophobia, phonophobia or nausea) associated with migraine at 2 h postdose.

Within the 48-h period postdose, 107 of 954 (11.5%) ubrogepant-treated (50 mg dose) patients and 113 of 984 (11.2%) placebo recipients experienced ≥1 treatment- emergent adverse event (TEAE), with no serious TEAEs reported in either group during this 48-h period (pooled ACHIEVE data; abstract) [40].

Acknowledgement A machine generated summary based on the work of Scott, Lesley J. 2020 in Drugs.

Rimegepant: First Approval