Indivior Plc said on Tuesday the U.S. Food and Drug Administration rejected its nasal spray for the emergency treatment of opioid overdose.
The company said it was reviewing the health regulator’s response.
These sprays contain naloxone, a drug that has been used to treat opioid overdose for nearly 45 years in injectable forms.
Last week, the FDA approved the first-ever nasal spray formulation of the drug made by privately held Adapt Pharma Ltd.
The FDA has been speeding up its review of new formulations of nalaxone to combat rising opioid abuse in the United States.
Data from the Centers for Disease Control and Prevention indicates opioid overdose led to about 23,500 deaths in the United States in 2013, a four-fold jump from 1999.
(Reporting by Amrutha Penumudi in Bengaluru; Editing by Anil D’Silva)
Source: Reuters Health