Skyepharma Plc (SKP.L, SKYE) said Thursday that the third phase III efficacy study of Flutiform for the treatment of mild to moderate asthma met its primary endpoints. Flutiform is a fixed-dose combination of formoterol and fluticasone in a metered-dose inhaler. The company is anticipating filing a new drug application or NDA for the drug with the U.S Food and Drug Administration after the completion of another clinical efficacy trial.
The study was a randomized, double blind, placebo-controlled, parallel group, 12-week study that compared the efficacy and safety of Flutiform 100/10 micrograms twice daily in a single inhaler with placebo or formoterol, in adolescent and adult patients with mild to moderate asthma. The study included 475 patients from across North America and Europe.
The Levels of improvement in forced expiratory volume in the first second of inhalation or FEV1, which was the primary endpoint, showed substantial difference in favor of Flutiform compared with both fluticasone and formoterol taken alone.
Also, the results showed significantly lower number of discontinuations due to lack of efficacy for Flutiform compared with placebo.
The company noted that the last clinical trial required for the U.S filing would be conducted by Kos Life Sciences, a wholly owned subsidiary of Abbott. The trial is expected to be complete by the second half of this year.
The results of this efficacy trial, along with the long-term phase III safety trial and two other efficacy trials would form part of the New Drug Application for U.S regulatory approval for Flutiform, which the company expects to file in the first quarter of 2009.
Shares of SKP.L are currently trading on the LSE at 6.30 pence up 10.53%, on a volume of 241,761 shares. SKYE closed regular trading on NASDAQ on June 13th at $25.55.
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