FDA staff flags concerns about Pfizer's quit-smoking drug study
Sept 12 (Reuters) - U.S. Food and Drug Administration scientists have expressed concerns about a post-marketing study of Pfizer Inc's drug Chantix, which is aimed at helping smokers quit, according to documents posted on the regulator's website on Monday.
The concerns are related to the trial design and data interpretation of the study, called Eagles, in more than 8,000 adult smokers.
The trial compared the effects of Chantix or GlaxoSmithKline Plc's Zyban with a placebo or a nicotine patch in patients with and without a history of psychiatric disorders.
Pfizer has been trying to get rid of a serious warning about neuropsychiatric side effects on the Chantix label.
The documents are part of a preliminary review ahead of a meeting of outside advisers on Wednesday to discuss the findings of the trial.
The panel will decide whether the black box warning, the most severe available, should be removed from the Chantix label.
(Reporting by Natalie Grover in Bengaluru and Toni Clarke in Washington; Editing by Kirti Pandey)
