Wyeth and Progenics start phase III trials for intravenous methylnaltrexone

Wyeth and Progenics have announced the launch of a new phase III trial designed to evaluate the safety and efficacy of intravenous methylnaltrexone in treating patients with post-operative bowel dysfunction, caused by the use of opioid drugs like morphine.

Methylnaltrexone has been developed to counteract the unwanted side-effects of opioid pain relief drugs, affecting the gastrointestinal tract in particular. The use of opioid drugs – although extremely effective in reducing pain – can prolong hospital stays.

Phase III trials for the subcutaneous form of the drug have already taken place, but Wyeth and Progenics claim there may be a need for an intravenous form, because of problems with ingestion following surgery.

Robert J Israel, senior vice president of medical affairs at Progenics, remarked: “Intravenous methylnaltrexone is designed to target an underlying cause of post-operative ileus, the unwanted interaction of opioids with the gastrointestinal tract.”

Ann Lowry, president of the American Society of Colon and Rectal Surgeon, added that the intravenous form of the drug would be a “convenient” method of delivery to counteract the “debilitating effect” of opioids on the gastrointestinal tract.

The collaboration between Wyeth and Progenics is part of a $400 million (211 million pounds) deal between the two companies, with the majority of the sum payable after certain milestone targets have been achieved.

Earlier this month, GlaxoSmithKline reported positive results for alvimopan, another treatment for post-operative bowel dysfunction. The UK company said it was working to bring the “important new medicine” to patients as quickly as possible.