Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced the initiation of an international 700-patient, phase 3 trial of oral methylnaltrexone in patients with chronic, non-cancer pain who are experiencing constipation as a result of their opioid-pain management regimens. The goal of the study is to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation (OIC) in this patient setting.
"An oral formulation of methylnaltrexone, if successfully tested and approved, would be an important addition to the RELISTOR® franchise," said Paul J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive and Chief Science Officer. "We have been pleased in the testing of this formulation to date. We look forward to confirming these results in this phase 3 clinical trial."
The phase 3 study will evaluate the oral formulation of methylnaltrexone that was tested in a formulation optimization clinical trial and reported on by Progenics on March 12, 2010. That trial examined the safety and activity of different dose levels of a tablet formulation of oral methylnaltrexone in subjects with chronic, non-cancer pain with a history of OIC receiving various opioid treatment regimens.
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