SkyePharma announces positive Flutiform paediatric results

SkyePharma has announced that Mundipharma, its marketing and development partner, has successfully completed a paediatric study for Flutiform with positive results.

Mundipharm has conducted a study in 211 children aged four to 12 with mild to moderate persistent and reversible asthma as part of the European development programme for the compound.

The study compared Flutiform at its lowest dose (100mcg fluticasone and 10mcg formoterol) with Seretide (100mcg fluticasone and 50mcg salmeterol).

Patients had a disease history of at least six months and received 12 weeks of treatment, with a six-month extension for a growth and safety follow up.

The trial met its primary endpoint of improvement in forced expiratory volume in the first second, while Flutiform was shown to not be statistically inferior to Seretide in this regard.

Frank Condella, chief executive officer of SkyePharma, said: “The successful conclusion of this paediatric trial comparing Flutiform with Seretide is a further important step in the development of the product and follows the successful completion of the long-term safety study in 2007.”

He added that the publication of this data is the first of a number of key announcements regarding the compound the company will make over the next few months as pivotal phase III trials of the drug reach completion.

Last month, SkyePharma reported continued progress with the development of Flutiform in the last financial year, with the completion of long term phase III safety trials and predicted filing for the drug in Europe at the end of 2008.