Wyeth submits OIC drug to EMEA

US drug major Wyeth has submitted a marketing application to the European Medicines Agency (EMEA) for a subcutaneous formulation of methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients with advanced illness.

The firm is developing the peripherally-acting opioid-receptor antagonist designed to treat OIC without interfering with pain relief together with the USA's Progenics Pharmaceuticals, which submitted a New Drug Application for the same formulation of methylnaltrexone to the US Food and Drug Administration on March 30.

The marketing application is based on data from two Phase III studies that evaluated the safety and efficacy of the subcutaneous formulation of methylnaltrexone in the treatment of OIC in patients with advanced illness. All of the primary efficacy endpoints of the studies were positive and statistically significant, and the therapy, generally, was well-tolerated, the firms noted.