Boy, FDA Can Move Fast When It Wants to!

The FDA announced the approval of Narcan (naloxone hydrochloride) Nasal Spray as an alternative emergency treatment for accidental opioid drug overdose.  Previously, naloxone hydrochloride, which reverses the effects of opioids very rapidly, was available only as an injection available in a syringe or auto-injector.

In a press release issued today (here), FDA notes that, because of potential concerns regarding possible unintended needle sticks from an at-risk population, it would be beneficial to have a nasal spray version available to consumers.  The FDA agreed and, according to their press release, approved the new version of the drug in 4 months, significantly in advance of their January 20, 2016 PDUFA goal date.  The product was granted Fast-Track designation and priority review status.

FDA goes on to discuss the problem with opioid abuse and overdose deaths and provides a strong rationale for not only attempting to reduce such abuse, but the public health need to potentially save the f lives of those who accidentally overdose on opioids.  FDA states: “Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes.”  This is truly a public health emergency and this product will add to the armamentarium of first responders, caregivers, and friends and families who have family members at risk.  Good job, FDA!