SAN DIEGO, July 23, 2018 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) announced today that it has been conducting pre-IND development work for a fast-dissolving sublingual tablet containing tadalafil. Adamis intends to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) before year end.
Tadalafil (Cialis®) is a drug used for treating erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia (BPH). Tadalafil is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors which includes, among others, sildenafil (Viagra®) and vardenafil (Levitra®). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED. Tadalafil and sildenafil are also indicated for pulmonary hypertension, but among PDE5 drugs, only tadalafil is approved for the treatment of BPH.
Adamis’ first goal in development and clinical testing will be to demonstrate comparability to Cialis® and additional benefits of a rapidly acting sublingual formulation.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “The theme throughout our expanding pipeline is to develop improved methods of delivering well-established drugs to compete within large, well-established markets. If we are able to achieve stated clinical objectives and our product is eventually approved, I feel there would be demand for our sublingual tadalafil product within the multibillion dollar ED market. We have developed a product and a clinical plan with the objectives of filing an IND and submitting an NDA before year end. Additionally, we continue to work on our naloxone product with the objective of filing an NDA before year end.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease and allergy. The company’s Symjepi (epinephrine) Injection 0.3mg, was approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and its Symjepi (epinephrine) Injection 0.15mg product is undergoing FDA review. Adamis recently announced a distribution and commercialization agreement with Sandoz, a division of Novartis Group, to market Symjepi in the U.S. In addition to the sublingual tadalafil candidate, Adamis is developing additional products using its approved injection device, a metered dose inhaler and dry powder inhaler devices. The Company’s U.S. Compounding, Inc. (USC) subsidiary compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.
Adamis 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 future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of the FDA’s review of an Investigational New Drug Application relating to its sublingual tadalafil product candidate, and the outcome of any further studies or trials relating to that product candidate; the company’s ability to commercialize its products and product candidates; the company's beliefs concerning the ability of its products and product candidates to compete successfully in the market; and the company's beliefs concerning the safety and effectiveness of its products and product candidates. 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 those contemplated by 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.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation