Adamis Pharmaceuticals Announces Submission of Investigational New Drug (IND) Application to the FDA for New Product Candidate for the Treatment of Opioid Overdose

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GlobeNewswire 4-Dec-2017 4:05 PM
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SAN DIEGO, Dec. 04, 2017 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (Adamis) announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin testing the drug compound naloxone in human patients. Adamis intends to develop a naloxone injection product candidate utilizing the same patented SymjectTM syringe drug delivery platform used in Adamis approved SymjepiTM product, which is an epinephrine injection drug/device combination for the emergency treatment of acute allergic reactions including anaphylaxis.
Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone, which is generally considered the drug of choice for immediate administration for opioid overdose, blocks or reverses the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.
According to statistics published by the Centers for Disease Control and Prevention (CDC), in 2016, drug overdoses resulted in approximately 64,000 deaths in the United States greater than 175 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50 and the proliferation of more powerful synthetic opioids, like fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses. The current epidemic of drug overdoses is killing people at a faster rate than the HIV epidemic at its peak.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, Since FDA approval of our Symjepi product, we have considered other drug candidates for use with our Symject syringe injection platform. We determined to pursue an IND for naloxone due to the worsening opioid crisis. With the rapid increase in fentanyl related deaths and the persistence of widespread opioid addiction, we believe that there is a need for additional treatment options to help combat this crisis. We are excited to be moving forward with naloxone and will continue to assess additional compounds for possible use with our injection platform.
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 companys first product, Symjepi (epinephrine) Injection 0.3mg, was approved in June 2017 for use in the emergency treatment of acute allergic reactions, including anaphylaxis. In addition to the naloxone injection product candidate, Adamis product pipeline includes HFA metered dose inhaler and dry powder inhaler products for the treatment of bronchospasm and asthma.
The companys 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 companys beliefs concerning the timing and outcome of the FDAs review of the companys Investigational New Drug Application relating to its naloxone product candidate, and the outcome of any further studies or trials relating to that product candidate; future developments concerning the opioid crisis in the United States; the companys 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 athttp://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.
Contacts: Mark Flather Senior Director, Investor Relations& Corporate Communications Adamis Pharmaceuticals Corporation (858) 412-7951mflather@adamispharma.com