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news.SkyePharma has reported that the Phase III, long-term, open-label, safety study for Flutiform, the company's lead development product for the treatment of asthma, has been completed.
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The results are consistent with the large safety database already accumulated on the individual constituents fluticasone and formoterol.
The study involved 472 patients who were treated with Flutiform for six or 12 months, and will form part of the US new drug application (NDA) for Flutiform. Three double-blind efficacy trials are currently ongoing, of which one is fully enrolled and the other two are nearing full enrolment. Submission of the NDA is expected in the second half of 2008.
Frank Condella, CEO of SkyePharma, said: “The results of this study are as we expected and represent a significant milestone achieved in the Flutiform development program. We continue to make good progress towards the approval of this exciting product.”