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Adamis Gets OK for NDA

Adamis Pharmaceuticals Corp (NASDAQ:ADMP) reported the submission of a New Drug Application for its naloxone pre-filled syringe.

The San Diego-based Adamis made the announcement on New Year’s Eve, saying the injection is designed for the treatment of an opioid overdose.

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 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

Said CEO Dennis J. Carlo, "This NDA submission represents another major milestone for Adamis this year. With the rapid increase in synthetic opioid 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."

ADAM shares gained 11 cents, or 4.9%, to $2.36