Further studies needed for aclidinium bromide
The USA's Forest Laboratories and Spain's Laboratorios Almirall have updated investors on the current status of the development of their candidate aclidinium bromide for the treatment of chronic obstructive pulmonary disease.
After consultation with the US Food and Drug Administration, the agency has decided that additional clinical studies of the drug will need to be conducted before an application can be submitted, including higher and/or more frequent doses.
The decision follows a meeting with the FDA to review the ACCLAIM/COPD I and II studies. The companies originally anticipated filing a New Drug Application in the fourth quarter of 2009 or the first quarter of 2010, depending on feedback.
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