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RELISTOR
(Opioid-induced Constipation in the Advanced-Illness Setting)
RELISTOR (methylnaltrexone bromide) is the first approved treatment for opioid-induced constipation (OIC).
In the U.S., RELISTOR (subcutaneous injection) is approved by the Food and Drug Administration (FDA) for the treatment of opioid-induced constipation in patients with advanced illness receiving palliative care, when response to laxative therapy has not been sufficient.
RELISTOR subcutaneous injection is also approved in over 30 other countries, including all 27 member states of the European Union and other nations in Europe, Latin America, Canada, and Australia.
In October 2009, Progenics and Wyeth Pharmaceuticals terminated their 2005 RELISTOR collaboration, as a result of which Progenics is regaining all worldwide rights to RELISTOR. Under their Transition Agreement, Wyeth is continuing to market and sell RELISTOR in the U.S. and elsewhere until approximately the end of 2010. Progenics is pursuing a range of strategic alternatives, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion with its own sales force for RELISTOR at the end of this transition period.
In Japan, Progenics has licensed the rights to the subcutaneous formulation of RELISTOR to Ono Pharmaceutical Co., Ltd., which is pursuing regulatory approval for marketing the drug in that country.
After launching RELISTOR in single-use vials in 2008, a supplemental New Drug Application (sNDA) is planned for submission to FDA for RELISTOR in pre-filled syringes.
RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com