SAN DIEGO, April 16, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq:ADMP) ("Company") today announced the results of a clinical efficacy trial that was conducted outside of the United States for its albuterol HFA product, APC-2000. The study was performed in 124 stable, mild to moderate asthmatic subjects and was designed to reflect the FDA's Albuterol Sulfate June 2013 Draft Guidance.
The primary objective of the study was to evaluate the therapeutic equivalence of Adamis' APC-2000 HFA with GlaxoSmithKline's (GSK) Ventolin Evohaler HFA. To achieve this, the primary endpoint chosen was the equivalence of change from baseline in Forced Expiratory Volume (FEV1 AUC 0-6 hours) between the two HFA aerosols assessed at two different doses (100 and 200 mcg).
The study was a randomized double blind, double dummy, four periods crossover, therapeutic equivalence study comparing Adamis' APC-2000 HFA with GSK's Salbutamol Sulphate HFA (Ventolin Evohaler). Two doses of each product were tested, 100 and 200 mcg doses. Each subject received 4 inhalers at each of the 4 periods. These contained two Ventolin (one or both was active or placebo) and two APC-2000 inhalers (one or both was active or placebo). Periods were randomized to reflect the order in which inhalers were taken in each period. There were two washout days between the periods.
The study met the clinical FEV1 primary endpoint and results confirmed the therapeutic equivalence between the test (APC-2000) and the reference product (GSK's Ventolin Evohaler). Both products were found to be safe and well-tolerated. The study also confirmed a significant difference in clinical efficacy between the two doses.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions, we predict that our drug (APC-2000) will be as safe and efficacious as Ventolin®. We expect that this will be confirmed in an upcoming Phase III study in which we will compare APC-2000 and Ventolin® 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, APC-2000 for the treatment of bronchospasms, 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.