Wyeth and Progenics announce results of methylnaltrexone study

Wyeth Pharmaceuticals and Progenics Pharmaceuticals have announced the positive results of a trial of methylnaltrexone as a treatment for opioid-induced constipation, with this data to be presented at the symposium of the Multinational Association of Supportive Care in Cancer in St Gallen.

The phase III clinical study investigated the use of subcutaneously-administered methylnaltrexone for three months to assess the safety and efficacy of the compound.

Patients who had previously received methylnaltrexone in an earlier study exhibited a 45.5 per cent mean laxation response rate during the first month, 57.7 per cent in the second and 57.3 per cent in the third.

For the patients who had received placebo in the earlier trial, the comparable response rates were 48.3 per cent, 47.6 per cent and 52.1 per cent.

Paul J Maddon, chief executive officer and chief science officer of Progenics, said: “These results show that methylnaltrexone, when administered subcutaneously for up to three months, continued to induce laxation in advanced illness patients with [opioid-induced constiptation].”

He added that data from this trial was recently included in submissions to the European Medicines Agency (EMEA), while both companies have confidence in the beneficial effect of the administration of subcutaneous methylnaltrexone.

Wyeth announced the regulatory submission of methylnaltrexone to the EMEA last month, reporting that the compound could have the potential to tackle a major adverse affect of opioid use.