Wyeth and Progenics Pharmaceuticals Announce Development Plans for Methylnaltrexone
Treatment platform comprising three formulations targets opioid-induced bowel dysfunction and post operative bowel dysfunction
Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, Inc. announced their plans for the further development of methylnaltrexone. Methylnaltrexone is an investigational drug that is being studied as a treatment for the peripheral side effects of opioid analgesics, without interfering with pain relief. Methylnaltrexone is being developed in three dosage forms: subcutaneous and oral forms as treatment platforms for opioid induced-bowel dysfunction, and an intravenous form for post operative bowel dysfunction. In December 2005, Wyeth and Progenics Pharmaceuticals entered into a collaboration to develop and commercialize methylnaltrexone.
Opioid analgesics such as morphine are widely used to treat patients with moderate to severe pain. However, opioid use often results in Opioid-induced bowel dysfunction (OBD), a combination of symptoms including constipation, nausea, abdominal discomfort, bloating and loss of appetite. OBD occurs when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal motility. The consequences are not only distressing, but may be severe enough to interfere with adequate pain control.
Progenics Pharmaceuticals has completed two phase 3 clinical trials in advanced illness patients with OBD using a subcutaneous form of methylnaltrexone. In early 2007, the companies plan to submit a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for this indication. If the NDA is approved, Wyeth plans a United States market launch soon thereafter. Following the United States submission, Wyeth plans to complete regulatory filings in Europe and the rest of the world for subcutaneous methylnaltrexone.
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