- As expected, the European Commission approves a new indication for Valeant Pharmaceuticals' (VRX) Relistor (methylnaltrexone bromide) for the treatment of adult patients with opioid-induced constipation (OIC) who have had an insufficient response to laxative therapy. This significantly expands the number of patients that are candidates for the drug.
- In April, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the expanded label.
- Relistor was originally cleared for the treatment of OIC in adult patients with advanced illness who are receiving palliative care when response to laxative therapy has been inadequate.
- Valeant obtained the rights to Relistor via its acquisition of Salix Pharmaceuticals which licensed it from developer Progenics Pharmaceuticals (PGNX).