LONDON, UK, 18 December 2007-- SkyePharma PLC (LSE: SKP) today announces that it has completed enrolment of patients into the three double-blind efficacy trials currently underway for FlutiformTM, its lead development product for the treatment of asthma.
The three efficacy trials, involving nearly 1,400 patients, will provide core clinical data for the New Drug Application (NDA) to be filed with the U.S. Food and Drug Administration (FDA) and will also support the European Marketing Authorisation Application (MAA). It is anticipated that the trials will be fully completed in April 2008. The trials are designed to demonstrate the superiority of FlutiformTM over the individual components and, in two of the studies, also over placebo.
