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FDA approves Adapt Pharma's opioid overdose nasal spray

Narcan aims to curb rise in deaths from opioid abuse
FDA

The FDA has approved Adapt Pharma's Narcan nasal spray to reverse the effects of an opioid overdose.

Narcan is a needle-free device that delivers a 4mg dose of the active ingredient, naloxone, in a single 0.1ml nasal spray. The spray can be administered in an emergency by family members, caregivers or others to reverse the opioid overdose until help arrives.

According to the FDA, the drug can counter the effects of an overdose as quickly as two minutes after it is administered.

Narcan had previously been granted Fast Track Designation and it has now received approval in just four months, well ahead of the product's prescription drug user fee goal date of January 20, 2016.

Acting FDA commissioner, Stephen Ostroff, said: “We cannot stand by while Americans are dying. “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 dangers come from prescriptions opioids such as morphine, codeine, methadone and oxycodone as well as illicit opioids like heroine and heroin/fentanyl mixes.

In the US, opioid overdose related deaths are growing and claimed almost 24,500 lives in 2013, or an average of one life every 21 minutes – the majority of these deaths involve prescription opioids that used at home.

From 2006 to 2010, heroin overdose deaths increased by 45% nationwide in the US.

Adapt Pharma originally licensed the device from Manhattan-based biopharmaceutical company Lightlake Therapeutics. 

Article by
Nikhil Patel

24th November 2015

From: Regulatory

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