Seretide® / Advair® substitute
Circassia’s product is a particle-engineered combination of the inhaled corticosteroid fluticasone propionate and long-acting beta agonist salmeterol xinafoate delivered via pressurized metered dose inhaler (pMDI). The product is in development as a direct substitute for GSK’s Seretide® / Advair® pMDI, which is used in the treatment of asthma.
Circassia is developing its product in a pMDI in the EU under the guidelines for orally inhaled products, which allow for approval without the need for large clinical trials. We also plan to seek approval in other markets, including the US where the FDA guidelines allow for pharmacokinetic and clinical endpoint or pharmacodynamic studies rather than large clinical programs. We anticipate filing for regulatory approval in Europe in 2017.
Pipeline status: Seretide® / Advair® substitute