SkyePharma has to provide more data to the US FDA regarding its new asthma drug Flutiform™.

SkyePharma is to provide more clinical data to the US Food & Drug Administration (FDA) regarding its new asthma drug, Flutiform™ – news that has sent its shares down by more than 4%.

The drug is designed for patients, over the age of 12, who experience persistent asthma. It is a fixed-dose combination of formoterol and the inhaled steroid fluticasone in a metered dose inhaler – it has an in-built dose indicator to improve patient convenience, is small, portable and easy to use.

In June, there were early indications from the FDA that the drug needed extra work and it has now confirmed that more clinical data is required regarding dosing of the drug.

Dr Ken Cunningham, Chief Executive Officer, said: “We now have greater clarity from the FDA on its approach to our filing and we are working to address these issues as soon as possible.

“Flutiform™ remains on track in Europe and Japan, and we remain confident that, once approved and launched in its various markets, Flutiform™ will be a successful product for SkyePharma in terms of both revenues and cash flows.”

The news means that the drug is unlikely to be approved before the second half of 2011.

SkyePharma is a leading speciality drug delivery company, headquartered in London. It specialises in developing oral and inhalation products, and often partners with other companies such as GlaxoSmithKline and AstraZeneca.