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FDA approves Relistor

Wyeth's Relistor has been approved by the US Food and Drug Administration for use in patients who are in the late-stage of an illness and receiving pain medication.

Wyeth's Relistor has been approved by the US Food and Drug Administration (FDA) for use in patients who are in the late-stage of an illness and receiving pain medication.

Relistor (methynaltrexone bromide) restores bowel function for patients being treated with opioids to relieve pain symptoms caused by diseases such as incurable caner and end-stage chronic obstructive pulmonary disease (COPD). Two randomised, double-blind placebo-controlled studies were conducted over a four-moth period that successfully established the drug's safety and efficacy.

Dr Joyce Korvick, deputy director of the division of gastroenterology products for the FDA, said: "This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illnesses."

Relistor is designed to block opioid entrance into the cells so regular bowel function can be preserved. Opioids can interfere with the passage of waste products by relaxing the intestinal smooth muscles rendering them unable to contract normally.

Bernard Poussot, president and chief executive officer (CEO) of Wyeth, said: "As Wyeth's third new medicine to receive FDA approval in 2008, Relistor is an excellent example of Wyeth's continuing commitment to develop and deliver medicines that work in novel ways and provide important new treatment options for patients."

The drug was developed as part of a joint venture between Wyeth and Progenics Pharmaceuticals.

Dr Paul Maddon, founder, CEO and chief scientific officer of Progenics, said: "The approval of Relistor is a transformative event for Progenics Pharmaceuticals."

"This program has greatly benefited from our collaboration with Wyeth to develop and commercialise the Relistor platform of products," he concluded.

25th April 2008

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