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Home Industry News SkyePharma completes Flutiform trial enrolment

SkyePharma completes Flutiform trial enrolment

19th December 2007

SkyePharma has confirmed that patient enrolment is now complete for the company’s current clinical trials for the development of Flutiform in the treatment of asthma.

Over 1,400 patients have been enrolled across three efficacy trials which are designed to demonstrate the superiority of Flutiform over the individual components and also over a placebo.

The studies are also intended to provide core clinical data for the SkyePharma’s New Drug Application (NDA) which is to be filed with the US Food and Drug Administration (FDA) shortly.

An anticipated European Marketing Authorisation Application will also draw on results from the trials which are expected to be completed by April 2003.

Dr Ken Cunningham, chief operating officer of SkyePharma, commented: “We have completed another important milestone in the development of Flutiform and remain focused on meeting all necessary requirements for the NDA filing.”

An additional open-label, clinical efficacy study has been agreed with the FDA involving 375 patients and will commence in early 2008.

The company recently announced the successful completion of a phase III study for Flutiform which involved 472 patients

Earlier this year, SkyePharma and Sciele Pharma announced that the FDA had accepted the two firms’ supplemental new drug application (sNDA) for a new Sular formulation.

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