Adamis Pharmaceuticals Submits New Drug Application to FDA for Its Naloxone Pre-Filled Syringe

Adamis Pharmaceuticals (NASDAQ:ADMP) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for its naloxone pre-filled single dose syringe (PFS) product candidate.

As quoted in the press release:

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.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “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. As the awareness builds for this growing epidemic, we are hoping to provide an affordable solution to patients at risk.  We are excited to be entering 2019 with the anticipated upcoming launch of Symjepi and having two NDAs under FDA review.  We are continuing to assess additional compounds for possible use with our injection platform and believe that we are well positioned for solid growth in 2019.”

Click here to read the full press release.