FlutiformTM - Results of Safety Study
LONDON, UK - 2 November 2007 -- SkyePharmaÂ today announces that the Phase III, long-term, open label, safety study for FlutiformTM, the Company's lead development product for the treatment of asthma, has been completed and 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 FlutiformTM for 6 or 12 months and will form part of the US New Drug Application ('NDA') for FlutiformTM. 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 FlutiformTM development programme. We continue to make good progress towards the approval of this exciting product.'
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.