FDA approves first nasal spray treatment for emergency-case opioid overdose
On Wednesday, the US Food and Drug Administration (FDA) approved nasal spray treatment for emergency-case opioid overdose for the first time ever. The Narcan (naloxone) nasal spray is developed by Ireland-based Adapt Pharma Ltd.
The spray is an antidote used for opioid overdose for nearly 45 years but earlier was allowed only in injectable forms.
The data from the US Centers for Disease Control and Prevention (CDC) has shown that opioid overdose has led to around 23,500 deaths in the country in 2013, which was a four-fold rise from 1999. The deaths have mainly taken place in non-medical situations, which has emphasized on the need for administering effective emergency involvement.
Seamus Mulligan, chief executive of Adapt Pharma, said that Narcan, which will be launched in January, is also likely to be widely covered by health insurance with reasonable co-pays.
Acting agency commissioner Dr. Stephen Ostroff said that fighting opioid abuse is the key priority of FDA. He explained, "While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose".
The nasal spray needs no assembly for instant use and is known to deliver a steady, measured dose. Clinical trials have shown that administering it in one nostril gave roughly the same or higher levels of naloxone like a single dose of the standard intramuscular injection.
Its use in opioid-dependent individuals could lead to severe withdrawal symptoms, such as diarrhea, body ache, fever, and increased heart rate.