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FDA Approves Nasal Spray that Reverses Opiod Overdose

The U.S. Food and Drug Administration (FDA) have today approved Narcan nasal spray, a life-saving medication that can reverse or stop the effects of opioid overdose.

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Prior to the nasal spray approval from the FDA, the medication for opioid overdose was only administered via injectable forms. A few individuals had been using unapproved naloxone kits that included an injectable formulation of naloxone with an atomizer that could deliver the drug nasally. Another 8,000 additional deaths involved heroin, which many addicts switch to after becoming addicted to more-expensive legal drugs.

Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. When administered quickly, naloxone can counter the overdose effects, usually within two minutes, according to the FDA.

“Combating the opioid abuse epidemic is a top priority for the FDA”, said Dr. Stephen Ostroff, M.D., acting commissioner of the FDA, in a press release.

For group purchasers who order Narcan Nasal Spray directly from Adapt Pharma, it will be available at a discounted Public Interest Price of $37.50, according to the company.

Clinical trials demonstrated that, when used as directed, blood levels of naloxone were similar to those achieved with FDA-approved naloxone injectors.

The Narcan device delivers 4 mg of naloxone, preferably while the patient is lying on his or her back.

However, the FDA cautioned that once the drug has been given, people should seek immediate medical treatment. The drug is not meant to replace medical care.

The National Institute on Drug Abuse (NIDA) is calling attention to the new formulation.

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Adapt bought the development and commercialisation rights to Narcan from London-based Lightlake Therapeutics in December 2014.

First Nasal Spray Version Of Opioid Antidote Naloxone Gets FDA Approval