Seretide® / Advair® substitute
Circassia is developing a particle-engineered formulation of the inhaled corticosteroid fluticasone propionate combined with the long-acting beta agonist salmeterol xinafoate, delivered via pressurized metered dose inhaler (pMDI). The product is targeting direct substitution of GSK’s Seretide® / Advair® pMDI, which is used in the treatment of asthma.
Circassia is developing its European product 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 the UK in 2019.
Pipeline status: Seretide® / Advair® substitute