Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its fast-dissolving sublingual tadalafil tablet. This product candidate is designed for the treatment of erectile dysfunction. Adamis submitted the NDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act.
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.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, stated, “The filing for the NDA for our tadalafil tablet represents an important milestone for our company. We are very pleased with the progress we have made with our tadalafil product candidate which we believe is well-positioned to compete in the large, multi-billion-dollar erectile dysfunction market. We look forward to working through the review process with the FDA and hope to bring this low-cost therapeutic alternative to the market.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy. The company’s Symjepi™ (epinephrine) Injection 0.3mg and 0.15mg products are FDA approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis is developing a sublingual tadalafil product candidate, a naloxone injection product candidate utilizing its approved injection device, and a metered dose inhaler and dry powder inhaler devices for the treatment of asthma. The company’s subsidiary, U.S. Compounding, Inc., 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 matters: the timing or outcome of the FDA’s review of the company’s NDA relating to its tadalafil tablet product candidate; the company’s beliefs concerning its ability to commercialize the tadalafil tablet product candidate if approved by the FDA and the ability of the product candidate to compete successfully if approved and commercialized; the company’s beliefs concerning the size of the markets in which the product candidate will compete if approved; the company’s beliefs concerning the safety and effectiveness of its products and product candidates; and other statements concerning our future operations and activities. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are only predictions, are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently differ materially from those described in this press release, which may cause Adamis’ actual results to be materially different from those contemplated by these forward-looking statements. The timing and outcome of the FDA’s review of our NDA is uncertain. There is no assurance that the FDA will approve the NDA relating to our tadalafil tablet product candidate or that other matters or events relating to the submission and regulatory review process under Section 505(b)(2) of the Food, Drug & Cosmetic Act will not differ from our expectations or result in delays in the regulatory approval process. In addition, forward-looking statements concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the Securities and Exchange Commission, we may require additional funding, and there are no assurances that such funding will be available if required. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks, and additional risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the SEC, including our annual report on Form 10-K for the year ended December 31, 2017, and our subsequent filings 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.