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news.Ono Pharmaceutical, a collaborator of Progenics Pharmaceuticals, has initiated a multi-center, randomised, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial of subcutaneous methylnaltrexone in Japan.
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Ono Pharma’s Phase 2 comparison study is designed to demonstrate efficacy and safety of subcutaneous methylnaltrexone in Japanese subjects.
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.
Ono Pharma said that the subcutaneous methylnaltrexone is already marketed in the US and in certain ex-US markets under the brand name Relistor.
Progenics Pharma founder CEO and chief science officer Paul Maddon said that Ono’s commencement of this trial is an important step for the expansion of the methylnaltrexone franchise into Japan.
"Their work complements ours in the US, 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," Maddon said.