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FDA fast tracks new Narcan delivery system

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Today, the United States Food and Drug Administration has approved a new prescription treatment that can be used by family members or caregiver to treat patients who are known or have been suspected of an opioid overdose. A form of Narcan, Evzio which is a naloxone hydrochloride injection, will deliver a single dose of the drug via a hand held auto-injection that can be carried easily in a pocket or held in a medicine cabinet. This treatment is for emergency treatment only which is characterized by decreased breathing or heart rates, or loss of consciousness.

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

According to FDA,” drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes” www.fda.gov In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. www.cdc.gov

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

The high-profile, opioid-related deaths of celebrities such as Heath Ledger, Cory Monteith, and Philip Seymour Hoffman have raised the public’s concern of the dangers of opioid overdose.

The FDA reports, “Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.

Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. www.fda.gov

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