SAN DIEGO, Feb. 12, 2018 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or “Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s supplemental New Drug Application (“sNDA”) for its low dose SymjepiTM product candidate for the emergency treatment of anaphylaxis. On February 9, 2018, Adamis received FDA correspondence relating to the company’s sNDA stating that the Agency had completed their filing review and had determined that the sNDA was sufficiently complete to permit a substantive review. The FDA further indicated that no potential review issues were identified and if no major deficiencies were identified in their continued review, they are targeting September 3, 2018 to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests.
Symjepi (epinephrine) Injection 0.3mg is an FDA-approved product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis, designed for patients weighing 66 pounds or greater. The low dose version (0.15mg) is intended to potentially treat patients weighing 33-65 pounds. Both Symjepi products are intended to provide two single-dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to allergic reaction to foods (such as nuts), insect stings or bites, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
The American Academy of Allergy Asthma and Immunology, or AAAAI, defines anaphylaxis as a serious life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by AAAAI reporting on findings from a 2009-2010 study, up to 8% of U.S. children under the age of 18 had a food allergy, and approximately 38% of those with a food allergy had a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine.
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 first product, Symjepi (epinephrine) Injection 0.3mg, was approved in June 2017 for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis’ product pipeline includes HFA metered dose inhaler and dry powder inhaler products for the treatment of bronchospasm and asthma.
The Company’s U.S. Compounding, Inc. (USC) subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug Quality and Security Act, compounds sterile prescription drugs, and certain nonsterile drugs, 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 the company’s prior approval supplement to its New Drug Application (NDA), relating to the Symjepi™ (epinephrine) Injection 0.15mg pediatric dose pre-filled syringe product candidate; the company’s ability to commercialize its products and product candidates; the timing and nature of the company’s commercialization plans for Symjepi; 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. There can be no assurances that the FDA will approve the prior approval supplement to the NDA relating to the pediatric dose product candidate, concerning the timing of any such approval, or that the product will be commercially successful if approved and introduced. The FDA review process is subject to a number of uncertainties. The FDA could request additional or different submissions or request additional data, information, materials or clarification, all of which could affect the timing and outcome of the review process. As a result, there can be no assurances regarding the timing or the outcome of the FDA’s review process relating to the Symjepi™ (epinephrine) Injection 0.15mg pediatric dose pre-filled syringe product candidate. In addition, the timing of a commercial launch of Symjepi will depend on a number of factors, including without limitation whether or not we enter into an agreement with a commercialization partner and, if we enter into such an agreement, the terms of any such agreement and the plans of the commercialization partner. As a result, there are no assurances regarding whether we will enter into an agreement with a commercialization partner regarding Symjepi, when we may enter into any such agreement, or the date of a commercial launch of Symjepi. 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. Any forward-looking statement in this press release speaks only as of the date on which it is made. Except to the extent required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.
Senior Director, Investor Relations &
Adamis Pharmaceuticals Corporation
Source: Adamis Pharmaceuticals Corporation