Direct substitutes and novel formulations

Directly substitutable medicines

Circassia’s particle-engineering technologies have the potential to enable the development of products that are therapeutically equivalent to existing medicines, in a range of strengths, in similar devices using identical formulations.  Achieving this with traditional production techniques is highly challenging, and therefore there are few products on the market with this unique combination of features.

Additionally, pursuing direct substitution of existing respiratory medicines has the potential to accelerate development because European guidelines permit marketing approval based on in vitro demonstration of equivalence.  In addition, the US Food & Drug Administration guidelines allow for pharmacokinetic and pharmacodynamic studies rather than large clinical programs.

Novel formulations

Circassia’s pipeline also incorporates novel formulations of approved drugs. These include two novel formulations for the specialist treatment of chronic obstructive pulmonary disease, including a fixed-dose combination containing a long-acting beta agonist and long-acting muscarinic antagonist.