Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label study compared 3 inhalations of APC-5000 to 3 inhalations of Advair Diskus in 16 healthy subjects over 4 treatment periods.
APC-5000 is delivered using the Taper DPI inhaler, which Adamis licensed in August 2013 from 3M Drug Delivery Systems. Because the fine particle fraction is higher than for the Diskus device, the company says, less of the drug is deposited in the mouth and throat, so less drug can be loaded to achieve the same therapeutic dose.
Adamis President and CEO Dennis J. Carlo commented, “Based on the study conclusions and the extent of PK similarities between APC-5000 and Advair, we predict that our product (APC-5000), while using less drug, will still be as efficacious as Advair for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This hypothesis will be tested in a Phase 3 study comparing the efficacy of APC-5000 and Advair for non-inferiority.”
Read the Adamis press release.
