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news.The FDA has extended by three months the action date for its review of the new drug application from Progenics Pharmaceuticals and Wyeth Pharmaceuticals for subcutaneous methylnaltrexone, which is being reviewed for the treatment of opioid-induced constipation in patients receiving palliative care.
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The FDA’s revised action date for methylnaltrexone is now April 30, 2008. The FDA, in its review of this new drug application (NDA), requested the results from a recently completed QT study of intravenous methylnaltrexone. This study, which was submitted to the FDA, reported that there was no evidence of an effect of methylnaltrexone on QT prolongation. The FDA recently notified Progenics that it needs the extended time to review fully this study.
Paul Maddon, founder, CEO and chief science officer, Progenics, said: “We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission. We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year.”