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Allergan migraine drug atogepant shows benefits, safety in mid-stage trial

Allergan PLC, the maker of the Botox treatment for wrinkles and migraine headaches, said its experimental migraine medicine atogepant met the main goal of a study, the latest development in the race to bring new therapies for the condition to market.

Statistically significant results from the phase 2b/3 study, known as CGP-MD-01, showed atogepant was better at reducing monthly headache days in adult patients with episodic migraines than placebo treatment, regardless of dose or regimen studied.

Atogepant, which was administered daily for over 12 weeks to patients experiencing migraines, was well-received. The most common side effects were nausea, fatigue, constipation, nasopharyngitis and urinary tract infection. There were no signs of hepatotoxicity, or damage to the liver, due to medicine intake. The liver safety profile for atogepant was similar when compared to placebo.

"This new migraine trial performed way ahead of expectations on safety," Umer Raffat, an analyst at Evercore ISI, said in a note to investors. "This is great for atogepant itself, but also a validation for oral CGRP class in general," he wrote, referring to the group of medicines that work by blocking calcitonin gene-related peptide, or CGRPs, to help prevent both chronic migraines — those happening more than half the days in a month — and episodic ones that occur less than half a month but are still relatively frequent.

Other companies developing medicines in the CGRP class include Eli Lilly and Co. and Teva Pharmaceutical Industries Ltd. Amgen Inc. and Novartis AG won U.S. approval for their migraine drug Aimovig in May.

Allergan will advance its clinical testing program for atogepant after talks with regulatory authorities. The Dublin-based pharmaceutical company is also developing a migraine treatment called ubrogepant, which is also a CGRP inhibitor.

Raffat estimates that there is a 75% probability that atogepant will reach peak sales of $2 billion to $2.5 billion.