Additional Naloxone Formulation Submitted to FDA for Review

Adamis announced that the New Drug Application (NDA) for its naloxone prefilled single-dose syringe has been submitted to the Food and Drug Administration (FDA).

Naloxone, an opioid antagonist, is used for the emergency treatment of known or suspected opioid overdose. It antagonizes opioid effects by competing for the same receptor sites. Naloxone reverses the effects of opioids, including respiratory depression, sedation, and hypotension.

“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,” stated Dr Dennis J. Carlo, President and CEO of Adamis.

Currently, naloxone is supplied in ampules and vials for IV, IM or SC administration, in a prefilled auto-injector, and as a nasal spray.

For more information visit AdamisPharma.com.