SkyePharma and Endo granted FDA approval of DepoDur

Published: 20-May-2004

UK pharmaceutical company SkyePharma and US-based Endo Pharmaceuticals have been granted US FDA approval for SkyePharma's New Drug Application (NDA) for DepoDur for the treatment of pain following major surgery.


UK pharmaceutical company SkyePharma and US-based Endo Pharmaceuticals have been granted US FDA approval for SkyePharma's New Drug Application (NDA) for DepoDur for the treatment of pain following major surgery.

Previously referred to as DepoMorphine, DepoDur is a novel single dose sustained-release injectable formulation of morphine.

'DepoDur represents the largest single commitment SkyePharma has made to product development, including funding the product through Phase III trials and building and sustaining a purpose-built manufacturing plant,' said Michael Ashton, ceo of SkyePharma. 'We expect its commercialisation to have a profound effect on the company's future.'

The clinical trial programme for DepoDur involved more than 1,000 patients in four different pain models and demonstrated the great potential of the product to improve the control of post-operative pain, he added.

According to Endo's chairman and ceo Carol A. Ammon, the company expects to be in a position to commercialise DepoDur by the end of 2004 provided SkyePharma is able to provide sufficient inventory to support the launch of the product.

  

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