BioCentury
ARTICLE | Clinical News

Forest to conduct more aclidinium trials

March 6, 2009 11:20 PM UTC

Forest (NYSE:FRX) said it will conduct additional clinical testing of aclidinium to treat chronic obstructive pulmonary disease (COPD) to "provide further support for the selected regimens, including higher and/or more frequent doses." The decision follows a meeting with FDA to review the Phase III ACCLAIM/COPD I and II trials, in which once-daily 200 ug aclidinium met the primary endpoint. Forest said timelines for clinical studies and an NDA submission are being determined. The company previously said it expected to submit an NDA to FDA in 4Q09 or 1Q10, pending FDA feedback. ...