The UK’s SkyePharma says that its Phase III safety study for Flutiform, the company's lead development product for the treatment of asthma, has been completed and produced results consistent with previous data.

The trial involved 472 patients who were treated with Flutiform (fluticasone and formoterol) for six or 12 months and the results will form part of a New Drug Application for the product which is expected to be submitted to the US Food and Drug Administration to be filed in the second half of 2008. SkyePharma added that three double-blind efficacy trials are currently ongoing, of which one is fully enrolled and the other two are nearing full enrolment. 

Chief executive Frank Condella said that results of this study “are as we expected and represent a significant milestone achieved in the Flutiform development programme”. He went on to say that  “we continue to make good progress towards the approval of this exciting product”.

Analysts at Landsbanki, who have a ‘buy’ recommendation on the stock, said that the news “supports our positive view on Flutiform and should reassure any investors with concerns regarding the new therapy". SkyePharma shares ended up 6.6% to over 16 pence, a welcome change from the slide they suffered in August when the FDA “unexpectedly queried one particular aspect of the design of the clinical trial programme” for Flutiform.

However September saw the firm issue a statement saying that talks with the regulatory agency led to an agreement on “an approach for the additional clinical work required” for the drug which will include a further study to provide more efficacy data. SkyePharma had originally hoped to file Flutiform in the first quarter of 2008.