FDA Rejects Nasal Opioid Overdose Treatment

Feb. 21, 2017

The U.S. Food and Drug Administration has rejected Amphastar Pharmaceuticals's application to market an intranasal version of its emergency opioid-overdose treatment.

The FDA identified issues with the user interface of the treatment. Amphastar sells the treatment, naloxone, in prefilled syringes. Kaleo Pharmaceuticals recently received criticism for raising the price of its naloxone device Evzio by 550 percent.

According to a Reuters report, Adapt Pharma has two nasal spray formulations approved by the U.S. FDA.

Read the Reuters report