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TARRYTOWN, N.Y., June 12, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) chief executive officer Mark Baker will comment on the FDA Advisory Committee meeting held this week, in a conference call tomorrow, Friday, June 13, at 8:30 a.m. Eastern Time.
The Advisory Committee meeting was originally announced in June 2013 in response to the appeal by Progenics' collaboration partner, Salix Pharmaceuticals (Nasdaq:SLXP), of the U.S. Food and Drug Administration's July 2012 Complete Response Letter in respect of Salix's supplemental New Drug Application for Relistor
® subcutaneous injection for treatment of opioid-induced constipation in patients with chronic non-cancer pain. The FDA has stated that it will take action under the appeal within 30 days after receiving input from the Committee.
To participate in the call, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 59562329. A live webcast will be available on the Media Center of the Progenics website,
www.progenics.com , and a replay will be available there for two weeks.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.
Important Safety Information for subcutaneous Relistor
Relistor is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of Relistor beyond four months has not been studied.
Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician. Use of Relistor has not been studied in patients with peritoneal catheters.