Wyeth, Progenics Get Relistor Marketing Approval in EU
Wyeth and Progenics have received EU marketing approval for Relistor subcutaneous injection for opioid-induced constipation (OIC).
The drug will be introduced on a country-by-country basis with the first launch expected later this month, Wyeth said, adding that Relistor (methylnaltrexone bromide), a mu-opioid receptor antagonist, is the first approved treatment for OIC in the EU.
The FDA and Health Canada approved the drug earlier this year, and a marketing application is under review by the Australian Therapeutic Goods Administration, Wyeth said. Applications also are pending in other countries.
In May, the companies announced mixed clinical trial results for Relistor, saying an oral formulation had positive results in a Phase II trial, but an intravenous formulation failed to meet primary and secondary endpoints in a Phase III study.
In December 2005, Wyeth and Progenics entered into an exclusive, worldwide agreement to jointly develop and commercialize methylnaltrexone.