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Home Industry News Wyeth and Progenics “enthusiastic” over methynaltrexone programme

Wyeth and Progenics “enthusiastic” over methynaltrexone programme

11th January 2008

Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have highlighted their enthusiasm for the methylnatrexone programme.

The drug is indicated to mitigate the side effects of opioids on peripheral receptors without interfering with pain relief in the central nervous system.

Wyeth and Progenics are working in partnership to develop the drug candidate, which has already been submitted for regulatory approval in the US and Europe.

In May last year, Wyeth submitted a marketing authorisation application to the European Medicines Agency (EMEA) and with its Marketing Authorisation Application now validated, it expects an EMEA review later this year.

Meanwhile, the two companies have announced that the US Food and Drug Administration (FDA) has extended the action date for its review of subcutaneous methylnaltrexone by three months.

As part of the FDA’s review of the New Drug Application, it requested results from a recently completed QT study of intravenous methylnaltrexone.

While the study reported no evidence of methylnaltrexone on QT prolongation, the FDA confirmed that it needed time to fully review the data.

Paul J Maddon, chief executive officer at Progenics, stated that the company was confident in its submission and commented: “We are enthusiastic about the entire methylnaltrexone programme”.

Also this week, Wyeth has announced that it has bought the global rights to develop and market an experimental pain drug from the Japanese pharmaceutical company Mochida

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