Benzinga | Dec 1, 2020 09:02AM EST

Adamis Pharmaceuticals Announces Planned Response To FDA Complete Response Letter For ZIMHI

SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced a planned response to a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding its New Drug Application (NDA) for Adamis' ZIMHI(tm) high dose naloxone injection product for the treatment of opioid overdose.



The CRL, received November 13, 2020, identified deficiencies that the FDA determined must be corrected before the Agency can approve the NDA, and provided recommendations needed for resubmission. FDA had not previously identified those deficiencies. Adamis intends to address all the deficiencies raised in the CRL and request that FDA approve the NDA. All of the company's responses to the deficiencies will be submitted before year end. The company will then ask the FDA for a Type A meeting. If the matter cannot be resolved with the FDA Division that sent the CRL, Adamis intends to appeal the matter within the agency through a Formal Dispute Resolution.

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "We believe our high dose naloxone product (ZIMHI) offers a greater possibility to save lives given the high rates of synthetic opioid (fentanyl) overdoses. As the COVID-19 pandemic increases, the number of deaths due to opioid overdoses has also risen. Currently, only lower dose naloxone products are available. Recently, the injectable Evzio products have been discontinued, leaving no available intramuscular products approved for the layperson. This leaves a therapeutic vacuum that our high dose product would automatically fill and potentially save thousands of lives."