Thursday, SkyePharma Plc (SKYE, SKP.L) announced that the final Phase III efficacy study involving Flutiform for the treatment of moderate to severe asthma in adolescents and adult patients met its primary endpoint. This successful completion of the trial would facilitate the filing of a New Drug Application with the U.S Food and Drug Administration, or FDA.
Flutiform HFA-MDI is a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler. The drug is currently licensed in the U.S to Abbott Respiratory LLC, a wholly owned subsidiary of Abbott.
The randomized, double-blind, active-controlled, parallel group, stratified, multi-center study, across the United States, Latin America and Europe, involved 438 patients. The study compared the safety and efficacy of Flutiform in a single inhaler, with the administration of fluticasone alone in two different formulations in adolescents and adult patients with moderate to severe asthma.
The primary endpoint of the study was the levels of improvement in Forced Expiratory Volume in the first second, or FEV1. The company said the results of the study showed statistical differences in favor of Flutiform, as compared to fluticasone taken alone.
Ken Cunningham, chief executive officer of SkyePharma, commented, "This final successful Phase III efficacy study is the last trial to be completed prior to the submission of the NDA which is on track for filing with the FDA in Q1 2009."
Shares of SKYE closed regular trading on June 13th on Nasdaq at $25.55.
SKP.L is currently trading on the London Stock Exchange, up 1.00 pence, at 178.00 pence.
For comments and feedback: editorial@rttnews.com