Wyeth and Progenics file methylnaltrexone with TGA
US drugmakers Wyeth and Progenics Pharmaceuticals have submitted a marketing application to the Australian Therapeutic Goods Administration seeking approval to market as subcutaneous formulation of methylnaltrexone for the treatment of opiod-induced constipation. Similar applications were filed with the US Food and Drug Administration and the European Medicines Agency (EMEA) earlier this year (Marketletters April 9 and May 21).
Like the European and US applications, the Australian filing includes data from two Phase III studies in which the drug demonstrated both safety and efficacy when used in the treatment of OIC. The TGA has 255 working days to review the application.
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