Skip to main content

Symjepi

Generic name: epinephrine
Treatment for: Allergic Reactions

Adamis Pharmaceuticals Provides Regulatory Update on Its Epinephrine Pre-Filled Syringe

SAN DIEGO, Aug. 06, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or “Adamis”) today provided an update on the status of and guidance for the resubmission of the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the treatment of anaphylaxis. On August 5th, the Company had a telephonic meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the agency’s March 27, 2015 Complete Response Letter (“CRL”).

Since receiving the CRL, and after obtaining additional feedback from a number of epinephrine auto-injector users, the Company has made several improvements to the performance, size and functionality of its PFS. Based on the Company’s interactions with the FDA to date, the Company plans to resubmit the NDA before year end, assuming successful continued product development efforts.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “With the substantial improvements made to our PFS, I believe that our planned resubmission will address the issues raised in the CRL. Additionally, our newly designed PFS will have a smaller carrying case, be more user-friendly and be more suitable for the retail market. We are excited about the positive attributes of our new PFS and look forward to getting back on track with the resubmission of our NDA.”

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 timing and outcome of the FDA’s review of the company’s NDA relating to its Epinephrine PFS product candidate and the company’s ability to satisfactorily respond to the matters raised in the FDA’s CRL relating to the Epinephrine PFS product; 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. There can be no assurances that the Company will successfully complete development of the PFS product candidate, that the FDA will approve the NDA following any resubmission by the Company, or that the product will be commercially successful if introduced. The Company will require additional funding to commercially launch the product. 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

Posted: August 2015

Related articles

Symjepi (epinephrine) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.