SAN DIEGO, March 3, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq:ADMP) ("Company") today 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."
About Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease, allergy, oncology and immunology. The company's current specialty pharmaceutical product candidates include the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease, and APC-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. The company's vaccine product candidates and cancer drug product candidates include TeloB-VAX, a cell-based therapeutic cancer vaccine and three drugs, APC-100, APC-200, and APC-300, for the treatment of prostate cancer.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations, including, but not limited to the following statements: the company's beliefs concerning the ability of its product candidates to compete successfully in the market; the company's beliefs concerning the safety and effectiveness of its product candidates; the results of any future clinical trials that the company may conduct relating to its product candidates; the ability to fund future product development; future revenues expected from any of its product candidates, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; and the intellectual property protection that may be afforded by any patents or patent applications relating to its products and product candidates. Statements in this press release concerning future events depend on several factors beyond the company's control, including receipt of adequate funding to support these activities, the absence of unexpected developments or delays, market conditions, and the regulatory approval process. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Except to the extent required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.
Mark Flather Director, Investor Relations & Corporate Communications (858) 412-7951 Mark Gundy External Investor Relations 972-240-1873