A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 30 Dec 2019

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At a glance

23 Dec 2019 According to an Allergan media release, U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVY (ubrogepant) for the acute treatment of migraine with or without aura in adults.The FDA approval for UBRELVY is based on four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002).
04 Dec 2019 According to an Allergan media release, FDA action on New Drug Application (NDA) expected in December 2019.
19 Sep 2019 Safety results (n=516) published in the Cephalalgia.

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