UK-based drugmaker SkyePharma says patient enrolment in three clinical trials, being conducted to generate extra information on the potential of its flagship combination asthma candidate Flutiform, is now complete.

The trials are designed to show that Flutiform - a unique combination of the fast onset long-acting beta-agonist (formoterol) and the most commonly prescribed steroid (fluticasone) - is superior to the individual components and placebo in treating asthma, and should satisfy the US Food and Drug Administration’s request for additional information made back in September, delaying the drug’s filing.

Following their completion in April next year, the studies, involving nearly 1,400 patients, will form the basis of the drug’s US New Drug Application, which is now scheduled to be filed in the second half of 2008 as opposed to the first quarter, as well as support registration in Europe, the group said.

Despite the setback earlier this year, SkyePharma and its US partner Abbott Laboratories have remained steadfast in their belief that Flutiform has the potential to become a blockbuster, challenging AstraZeneca's Symbicort (budesonide and formoterol) and Advair/Seretide (salmeterol and fluticasone) from GlaxoSmithKline.