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| PGNX > SEC Filings for PGNX > Form 8-K on 1-Oct-2009 | All Recent SEC Filings |
1-Oct-2009
Other Events
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) has been informed by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), with which Progenics collaborates in the development and commercialization of RELISTOR®, that it has completed enrollment in a phase 3 one-year, open-label safety study of subcutaneous RELISTOR in over 1,000 chronic, non-cancer pain patients. The study enrolled ahead of anticipated schedule.
This study, initiated in December 2008, is designed to support planned supplemental regulatory filings in the U.S., Europe and elsewhere for approval of RELISTOR to treat opioid-induced constipation in the chronic-pain setting, an additional indication beyond than that for which the drug is currently approved.
In December 2008, Progenics and Wyeth initiated this safety study in accordance
with U.S. Food and Drug Administration International Conference on Harmonization
(ICH) Guidance, available at
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129517.pdf.
Progenics and Wyeth expect to present a consolidated safety database from this study and a 470-patient efficacy study in chronic, non-cancer pain patients, the results of which were announced in May, as part of supplemental regulatory filings which are planned for by the end of 2010.
RELISTOR is currently approved over 30 countries for the treatment of OIC in patients with advanced illness receiving palliative care.
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