BRIEF—NDA filing for ubrogepant on track for early 2019

Ireland-incorporated Allergan has announced the completion of two positive safety and tolerability studies of ubrogepant for the acute treatment of migraine, with the news leading to a 1.6% rise to $191.00 in the firm’s share price by close of trading on Wednesday.

The first study (UBR-MD-04) evaluated the long-term safety and tolerability of ubrogepant (50mg and 100 mg) compared to usual care for the acute treatment of migraine in adults for one year.

The second study (3110-105-002) evaluated the hepatic safety and tolerability of ubrogepant 100mg compared to placebo in healthy study participants over eight weeks.

Based on the completion of these safety studies for ubrogepant and previously reported efficacy and safety results from the ubrogepant ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02) studies, Allergan will submit a New Drug Application (NDA) to the US Food and Drug Administration by the first quarter of 2019.

Allergan anticipates that the ubrogepant NDA will be the first oral CGRP receptor antagonist submitted in the USA for the acute treatment of migraine with or without aura.