NEW YORK (Reuters) – Allergan Plc on Friday announced positive results from a second Phase III trial for the 50 milligram dose of its drug for acute migraine, reproducing results from the previous trial.
A lower dose of the drug, ubrogepant, failed to meet one of the study’s two main goals, the company said.
Wall Street is focused on the company’s pipeline of drugs in development as Allergan faces new, cheaper competition for its Restasis eye treatment and Namenda XR for Alzheimer’s disease. Allergan has said that it believes the migraine drug could reasonably bring in $500 million a year.
In February, the drug company reported positive results for the 50 and 100mg doses of the pill in another late-stage trial.
This trial backs up those results for the 50mg dose, David Nicholson, Allergan’s Chief Research and Development Officer said in an interview.
“You have to show that a drug reproducibly demonstrates benefit in the population that you intend to treat. We now have two adequate and well controlled studies clearly demonstrating the benefit of ubrogepant in the acute treatment of migraine,” Nicholson said.
In the trial of more than 1,300 patients, 21.8 percent were pain-free two hours after taking the 50mg dose versus 14.3 percent on placebo. About 39 percent in the 50mg group also reported the absence of their most bothersome symptom (MBS), such as nausea or sensitivity to light or sound, compared with 27.4 percent for placebo. Both results were deemed statistically significant.
The 25mg dose, while providing pain relief, was not significantly better than placebo on the MBS measure.
The treatment belongs to a class of migraine drugs also being developed by Eli Lilly, Amgen and Alder Biopharmaceuticals that target a protein associated with pain signaling called CGRP.
Some of these are injected therapies designed to prevent chronic migraines. Ubrogepant is intended to relieve migraine pain and other symptoms after their onset.
Allergan said it is still on track to file for U.S. approval next year, and believes it will be the first oral CGRP on the market. It has two longer-term safety studies to complete this year.
There have been some concerns about liver toxicity with drugs in this class. Allergan is confident that its drug does not cause liver problems for patients.
“We have no reason to believe that ubrogepant has any propensity to induce liver injury,” Nicholson said.
Reporting by Michael Erman; Editing by James Dalgleish
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