SkyePharma files Lodotra with EU regulators

SkyePharma, the British pharmaceutical company, has announced it has filed Lodotra with EU regulators in conjunction with Nitec Pharma.

The application comes as the companies announced “positive” phase III clinical trial data for the drug, which is a modified-release form of low-dose prednisone for use in rheumatoid arthritis.

SkyePharma claims that the drug provides the same benefits as the standard immediate-release form of prednisone, except the new form can also reduce morning stiffness experienced by many rheumatoid arthritis sufferers.

The phase III trial compared Lodotra, developed using Geoclock technology, to the immediate release form of the drug, revealing that Lodotra “significantly” reduced morning stiffness, while no change was observed in the immediate release group.

Frank Condella, chief executive officer of SkyePharma, commented: “We are extremely pleased with this validation of our Geoclock technology in this area of high unmet need, through these successful Phase III trials and the filing in the EU.”

He added that the technology has the ability to be applied across several therapeutic indications.

Last week, SkyePharma reported its interim results, showing that pre-tax losses had increased to 26.4 million pounds.

However, Mr Condella said the company had made “significant progress” and had expanded its development pipeline while improving efficiency at the company.