SkyePharma issues update on Flutiform

SkyePharma has issued a statement regarding its lead development product for the treatment of asthma – Flutiform.

Last month, the company held a routine pre-new drug application meeting with the US Food and Drug Administration (FDA) regarding the compound for discussion son its planned filing with the regulatory body.

Consequently, SkyePharma has reported increased confidence regarding the chemistry, manufacture and control development of the drug, though notes that the FDA has “unexpectedly” questioned one aspect of its clinical study programme.

As a result of this query, SkyePharma has concluded that it may be necessary to generate further clinical trial data to satisfy the regulator.

Frank Condella, chief executive officer of the company, said: “Flutiform’s potential is exciting due to its unique combination of the fastest onset long-acting beta-agonist (formoterol) and the most commonly prescribed steroid (fluticasone).”

He added that the possible need for further clinical trial data may delay the filing for the drug, but added that the firm was otherwise happy with the progress made and encouraged by the support of its US-partner, Abbott Laboratories, for the programme.

In November 2006, SkyePharma described the acquisition of Kos Phamaceuticals by Abbott as a “positive” development in the progress of Flutiform.