Final Decision from European Commission Expected by Mid-2008
COLLEGEVILLE, Pa. and TARRYTOWN, N.Y., April 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received a positive opinion for RELISTOR(TM) (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of RELISTOR in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR will now be forwarded to the European Commission for a final decision, which is anticipated by mid-year.
RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.
About the Subcutaneous RELISTOR Clinical Investigational Program
In March 2007, Progenics submitted a New Drug Application for
subcutaneous RELISTOR for the treatment of opioid-induced constipation
(OIC) in patients receiving palliative care to the U.S. Food
|SOURCE Wyeth Pharmaceuticals|
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