“Indivior PLC today announced that the New Drug Application (NDA) for naloxone nasal spray was accepted and received Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of opioid overdose. This naloxone nasal spray comes as a pre-filled device that contains naloxone specially formulated for optimal absorption into the nasal mucosa. The device has been designed to require minimal training so individuals may be better equipped to help an opioid overdose victim.
Naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the United States. Naloxone nasal spray is designed to deliver naloxone through the nasal mucosa of an overdose victim.
Currently, only needle-based formulations of naloxone are FDA approved.
The FDA’s Priority Review status accelerates the review time from 10 to 6 months from the day of NDA acceptance and is given to medications that may offer significant advances in treatment effectiveness or may provide a treatment where no adequate therapy exists.6 At this time, the FDA’s response to the NDA for naloxone nasal spray is expected late in the fourth quarter of 2015.”
Source: PRNewsire.com – July 29, 2015