WASHINGTON (dpa-AFX) - U.S. Drug manufacturer Forest Laboratories Inc. (FRX) and Spanish pharmaceutical company Almirall, S.A Tuesday announced positive results form a six month phase III trial evaluating fixed doze combinations of aclidinium bromide, and formoterol fumarate delivered by Almirall's inhaler Genuair, Pressair in the USA.
The firms further said they expect results from a second Phase III study in the coming weeks. Should the second trial be successful too, those results combined with the positive results of this one will support their intention to file an NDA with the FDA and an MAA to the EMA, added the companies.
Both fixed-dose combination treatment arms, 400/6mcg and 400/12mcg given twice a day, were said to be well tolerated in the study with the most common adverse events being nasopharyngitis and back pain.
Commenting on the development, Bertil Lindmark, Chief Scientific Officer at Almirall said, 'We expect this novel combination of aclidinium/formoterol to offer patients a new option in COPD treatment.'
COPD, or chronic obstructive pulmonary disease, is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe.
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