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FDA approves opiate antidote

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On Thursday the U.S Food and Drug Administration made the decision to approve a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The drug, Evzio, has now been approved as a single dose of the drug naloxone via a hand-held auto-injector. Naloxone is also known widely as Narcan. www.fda.gov

According to Kaléo, the pharmaceutical company which makes Evzio, “The new drug application (NDA) for EVZIO was granted Fast Track status and received a priority review by the FDA, which are regulatory pathways to accelerate the review and approval of products that fill an unmet medical need. EVZIO is expected to be available this summer through all major pharmacies and via mail order with a healthcare professional’s prescription. An assistance program will be available to help patients gain access to EVZIO” http://www.kaleopharma.com/u-s-food-and-drug-administration-approves-kal...

EVZIO is the first and only naloxone auto-injector intended to be available for immediate administration by family members or caregivers for suspected opioid overdose in settings where opioids may be present. Opioid overdoses are marked by slowed breathing, extreme fatigue and changes in heart rate. Because victims tend to lose consciousness and fall ill quickly, allowing nearby family members or caretakers to administer naloxone rather than waiting on paramedics or doctors could mean the difference between life and death.

FDA Commissioner Margaret A. Hamburg told reporters Thursday, calling Evzio “an extremely important innovation that will save lives.www.fda.gov Hamburg continued, “For years, the lack of a lay-friendly delivery system has made it difficult to make naloxone broadly available to the public and to foster its use in non-medical settings, where it is often most urgently needed. www.fda.gov Continuing, Hamburg, stated, “Evzio is not a substitute for immediate medical care.”

According to the Centers for Disease Control and Prevention more than 16,000 people died in 2010 due to opioid-related overdoses, driven largely by prescription drug overdoses, according to the most recent year for which data was available.

Naloxone has long been used in ambulances and emergency rooms to treat opioid overdoses. Now Evzio allows caregivers, family members and non-medical personnel to keep naloxone on hand, according to the FDA.

According to the FDA, “In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe.” www.fda.gov Naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.
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. There has been a large number of communities and states taking action to enable emergency personnel such as police officers and fire fighters, to use the Narcan as an antidote for overdoses in opiate users.

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