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AstraZeneca seeks EU approval for new Pulmicort formulation

SkyePharma has reported the move of developmental partner AstraZeneca to submit an application to European regulators seeking approval to market a new formulation of their Pulmicort asthma inhaler.

The new version of the inhaled corticosteroid Pulmicort will be available in two strengths, 100g and 200g, and will be used for the treatment of asthma in adults and children.

The current pMDI formulation of Pulmicort has been on the market since 1981 and uses chlorofluorocarbons (CFCs) as the propellant. This will now be replaced by a non-ozone depleting device using hydrofluoroalkanes (HFA) as propellant.

SkyePharma developed the new HFA pMDI device and conducted the clinical development program for AstraZeneca. The firm will also earn a royalty on AstraZeneca’s sales of the new formulation.