Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the initiation of a phase 2 clinical trial of subcutaneous methylnaltrexone in Japan by its collaborator, Ono Pharmaceutical Co., Ltd. (OSE-TYO: 4528). The drug, designated ONO-3849 in Japan, is being evaluated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness such as cancer. Subcutaneous methylnaltrexone is already marketed in the U.S. and in certain ex-U.S. markets under the brand name RELISTOR®.
“Their work complements ours in the U.S., where we are planning to submit a supplemental New Drug Application for subcutaneous RELISTOR in chronic, non-cancer pain patients, and recently have initiated a phase 3 study of oral RELISTOR.”
"Ono's commencement of this trial is an important step for the expansion of the methylnaltrexone franchise into Japan," said Paul J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive and Chief Science Officer. "Their work complements ours in the U.S., where we are planning to submit a supplemental New Drug Application for subcutaneous RELISTOR in chronic, non-cancer pain patients, and recently have initiated a phase 3 study of oral RELISTOR."
Ono's phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study is designed to demonstrate efficacy and safety of subcutaneous methylnaltrexone in Japanese subjects.
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