SkyePharma gets UK approval for DepoDur

SkyePharma has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved DepoDur, its morphine product designed to relieve pain after major surgery.

The company describes the drug as an injectable morphine variant, to be administered in single doses to take advantage of its sustained-release abilities. DepoDur, formerly known as DepoMorphine, was licensed to Zeneus for distribution in the EU, but SkyePharma had the rights returned following Zeneus’s acquisition by Cephalon.

Frank Condella, chief executive of SkyePharma, said: “We are delighted with the approval of DepoDur in the UK and are confident that this will lead to additional approvals in other European markets under the Mutual Recognition Process.”

The DepoDur trial involved over 1,000 patients and the company said it demonstrated the product’s “great potential” in improving post-operative pain. DepoDur uses the company’s DepoFoam technology which enables slow-release. It is available in the form a of a ready-to-use suspension.

Last week SkyePharma posted net losses of more than 50 million pounds, an increase of 32 million pounds on 2004’s losses. The company said it was partly due to increased development costs of Flutiform, which it bore without a partnering company. It added that it intended to sell its expensive injectables business.

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