SAN DIEGO, Feb. 24, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq:ADMP) ("Company") today announced the results of its pharmacokinetic (PK) study for its beclomethasone dipropionate HFA product, APC-1000. The study was a Phase I open label, randomized, single-dose, four-way crossover PK study comparing Adamis' APC-1000 (Beclomethasone Dipropionate HFA, ["BDP"] 80 mcg Inhalation Aerosol) to Teva Respiratory, LLC's Qvar® (Beclomethasone Dipropionate HFA, 80 mcg Inhalation Aerosol).
Twenty-two healthy male and female subjects who met the study inclusion criteria were enrolled. The study involved a screening period before randomization and four treatment periods each separated by a minimum of three days. Both Inhalation Aerosols were administered to each subject for a total dose of 320 mcg BDP (4 inhalations). Twenty-one subjects completed the study. One subject was withdrawn due to non-compliance.
The purpose of this PK study was to compare the bioavailability of APC-1000 to Qvar®. The results show the extent of absorption of APC-1000 to be equivalent to Qvar®.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions and the extent of PK similarities between APC-1000 and Qvar®, we predict that our drug (APC-1000) will be as safe and efficacious as Qvar®. We expect that this will be confirmed in an upcoming Phase III study initiated this year in which we will compare APC-1000 and Qvar® 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.
Source:Adamis Pharmaceuticals Corporation