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Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced the results of its pharmacokinetic (PK) study for its dry powder inhaler product, APC-5000. The study was a Phase I PK study comparing the bioavailability of Adamis' APC-5000 Dry Powder Inhaler (DPI) to GlaxoSmithKline's Advair® Diskus® DPI.
This PK study was designed as an open-label, randomized, single-dose, 4 period (2 sequence, 2 treatment, fully replicated) crossover relative bioavailability study comparing APC-5000 (Fluticasone Propionate (FP) 186 µg and Salmeterol Xinafoate (SX) 44.7 µg; 3 inhalations; total dose 558/134.1 μg FP/SX) and Advair® Diskus® 250/50 µg (3 inhalations; total dose 750/150 μg FP/SX). Sixteen healthy male and female subjects who met the study inclusion criteria were enrolled into the study. The study involved a screening period and four treatment periods separated by four days. After completion of screening procedures, subjects were randomized to receive two doses of each Test and Reference product in four treatment periods. All sixteen subjects completed the study.
APC-5000 utilizes the patented Taper DPI inhaler device which, in this case, has been developed to eliminate the need for complex powder treatments and additive substances such as lactose, i.e. there is no need for excipients. It was also developed to deliver a higher percentage of fine particles to the airways with better delivery efficiency, and by doing so, decrease the drug deposition in the throat and mouth. Because of this increased efficiency, less amount of drug is loaded into the device thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirm that systemic exposure to the drugs FP and SX is reduced after treatment with APC-5000, as compared to Advair® Diskus®, thereby potentially increasing the overall safety of the product.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “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 III study comparing the efficacy of APC-5000 and Advair® for non-inferiority.”
