Wyeth submits extension application for RELISTOR to EMEA

Wyeth and Progenics Pharmaceuticals have announced the submission of an extension application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system – pre-filled syringes.

In a statement, the companies explained that the therapy, which is used for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, received approval last year in single-use vials.

Should approval be granted, the company expects pre-filled syringes of RELISTOR to be available in Europe as soon as the first half of 2010.

The single-use vials of the drug will continue to be available.

Paul Maddon, founder, chief executive and chief science officer of Progenics Pharmaceuticals, said: “The development of RELISTOR in pre-filled syringes is an important step in our plans to make this medication available in more convenient forms.”

Last month, Wyeth announced its first-half earnings results and raised its guidance for 2009 full-year diluted earnings per share – excluding certain significant items – to a range of $3.48 (2.07 pounds) to $3.58.