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Home Industry News SkyePharma announces positive Flutiform results

SkyePharma announces positive Flutiform results

23rd July 2008

SkyePharma has announced the publication of positive results for two phase III European studies for Flutiform (fluticasone and formoterol) conducted by its development and marketing partner Mundipharma.

The first, FLT-3501, involved 182 patients with mild to moderate-severe persistent and reversible asthma and compared Flutiform to Seretide (fluticasone and salmeterol) with the goal of comparable efficacy between treatment arms.

Study FLT-3505 assessed 196 patients with the same condition, this time comparing Flutiform with its individual components fluticasone and formoterol, again to show non-inferiority when measured by FEV1 (Forced Expiratory Volume in the first second).

Flutiform HFA-MDI is a fixed-dose combination medication delivered in a metered dose inhaler, incorporating fast onset long-acting beta agonist formoterol with commonly prescribed inhaled stroid fluticasone, together with hydrofluoroalkane, an environmentally-friendly aerosol propellant.

Dr Ken Cunningham, chief operating officer at SkyePharma, said: “We are delighted that along with the three phase III pivotal efficacy studies conducted for new drug application submission, we now have two further phase III studies for European regulatory submission that have met their primary endpoints.”

Earlier this month, SkyePharma noted plans by Mundipharma to review the filing and marketing of Flutiform in Europe following discussion with authorities and its advisers.

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