FDA delays review of Wyeth, Progenics bowel drug
BOSTON, Jan 10 (Reuters) - Wyeth WYE.N and Progenics Pharmaceuticals Inc (PGNX.O) said on Thursday that U.S. regulators have delayed a review of their experimental drug to treat opioid-induced constipation in order to further review certain safety data.
The companies said the U.S. Food and Drug Administration has asked for the results of a recently completed study of the drug, methylnaltrexone, on QT prolongation, a disorder of the heart's electrical system that can lead to a life-threatening form of ventricular tachycardia in which the heart is unable to pump blood throughout the body.
The companies said the study submitted to the FDA examined the effect of intravenous methylnaltrexone, which is being developed for post-operative ileus, a dysfunction of the gastrointestinal tract following surgery.
The companies said there was no evidence of an effect of the drug on QT prolongation. They said the FDA now hopes to act on the drug around April 30, three months later than previously.
The companies are seeking to market a subcutaneous version of the drug for constipation associated with the use of opioid painkillers. (Reporting by Toni Clarke, editing by Gerald E. McCormick)
