EBS - The FDA Really Wants These Opioid Overdose Drugmakers to Succeed
The Food and Drug Administration really wants to see an over-the-counter (OTC) version of the opioid overdose medication naloxone -- so much so that it's doing the legwork needed to get the ball rolling.
In a statement on Friday, the agency noted:
In January, we took an unprecedented step in helping to encourage development of OTC naloxone products. To encourage drug companies to enter the OTC market, the FDA designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone. To do this, we developed a model Drug Facts label (DFL) with pictogram instructions so anyone with access to the drug can better understand how to administer it. To ensure the pictograms are easy to understand, we also conducted label comprehension testing with consumers. This was the first time the FDA proactively developed and tested a DFL to support development of an OTC product.