The company announced that a safety study on Flutiform (fluticasone/formoterol) had been completed and the results were consistent with the large safety database already accumulated on the two active pharmaceutical ingredients (APIs) that make up the fixed-dose combination drug.
"The results of this study are as we expected and represent a significant milestone achieved in the Flutiform development programme. We continue to make good progress towards the approval of this exciting product," SkyePharma chief executive Frank Condella said in a statement.
Flutiform combines the long-acting bronchodilator (formoterol) with the inhaled steroid fluticasone in a metered dose inhaler.
Tipped to be a $1bn-a-year- blockbuster, Flutiform, if approved, would enter a combination drug market currently only occupied by GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) and AstraZeneca's Symbicort (budesonide and formoterol).
But Flutiform's progression towards approval has been hindered after the August announcement the New Drug Application (NDA) would be delayed in the US.
Originally planned for submission in the first quarter of next year, the NDA for Flutiform would now not be submitted until the second half of 2008 following the request from the US Food and Drug Administration (FDA) for another clinical study to provide additional efficacy data.
The details of this extra study, expected to cost the company somewhere in the order of £3m ($6.3m) to £5m ($10.4m), are expected to be finalised soon.
Meanwhile, the company has three double-blind efficacy trials currently ongoing, of which one is fully enrolled and the other two are nearing full enrolment.
The results from the completed safety study will go towards the NDA submission.
The US setback would not affect the European submission of Flutiform, which is expected to be at the end of next year.
The US market for asthma drugs exceeded $10bn in 2005 and the fastest growing segment of this market is fixed combination treatments.
