Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News SkyePharma announces positive Flutiform phase III results

SkyePharma announces positive Flutiform phase III results

19th June 2008

SkyePharma has announced that its second phase III efficacy study for Flutiform (fluticasone proprionate and formoterol fumarate inhalation aerosol) has met its primary endpoints.

The Sky2028-3-004 study included a total 0f 557 patients in Europe and the US and was carried out out in preparation of a regulatory filing for the compound.

According to the trial results, Flutiform showed statistically significant differences in FEV1 (forced expiratory volume in the first second) when compared with fluticasone and formoterol taken alone.

Furthermore, significantly fewer patients discontinued use of the drug compared to placebo due to lack of efficacy.

Frank Condella, chief executive officer of SkyePharma, said: “The preliminary results from this second double-blind, phase III study provide evidence of efficacy in moderate to severe asthma and represent another major step forward in the development of Flutiform.”

He added that the last patient visits for a third phase III study of the compound took place in April 2008 with the results expected shortly.

In April 2008, SkyePharma announced that its marketing and development partner Mundipharma had completed a paediatric study of Flutiform with positive results.

The compound met its primary endpoint of improving FEV1 while showing non-inferiority to Seretide (fluticasone propionate and salmeterol).

We currently have 5 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.