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FDA Approves EVZIO for the Emergency Treatment of Opioid Overdose

Thu, 04/03/2014 - 11:01am

Kaleo announced that the FDA has approved EVZIO (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. 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. Opioids are part of a class of pain medications that work by binding to receptors in the brain that affect the body's perception of pain, and can cause fatal overdose when the amount of drug in the body is too high.

Opioids are used to treat pain associated with a variety of acute and chronic medical conditions. According to the Institute of Medicine, chronic pain affects about 100 million American adults - more than the total affected by heart disease, cancer and diabetes combined. More than 16,000 Americans die each year from prescription opioid overdose, and accidental drug poisoning has surpassed automobile collisions as the leading cause of accidental death in the U.S., driven largely by prescription opioids. Naloxone, the active ingredient in EVZIO, has been used for more than 40 years for reversal of respiratory depression due to opioid overdose, but has been primarily used by emergency medical services, other medical professionals and in limited naloxone distribution programs. EVZIO will be available to patients and their family members or caregivers via a healthcare professional's prescription.

EVZIO should be administered as quickly as possible when an opioid overdose is suspected because prolonged respiratory depression may result in damage to the central nervous system or death. Because people experiencing an opioid overdose generally lose consciousness, in most cases, family members or caregivers will likely be the ones who administer EVZIO. EVZIO uses voice and visual cues to assist in guiding a user through the injection process. "Kaleo was founded on the idea that patients are true experts on how their conditions impact their lives, and EVZIO was developed with patient and caregiver input throughout to make sure it would be easy to use in stressful opioid emergencies with limited training," said Eric Edwards, MD, PhD, Chief Medical Officer of kaleo. "Immediate availability of EVZIO for family members and caregivers to administer during a suspected opioid overdose has the potential to save many lives." "All patients taking an opioid pain medication accept some risk of potential overdose. No medication is side effect free, and potent pain relieving opioids have a narrow window of effectiveness, with some very serious possible side effects including potentially life-threatening respiratory depression," said Allen Burton, MD, anesthesiologist and pain specialist at Houston Pain Centers and former chairman of the department of pain medicine at the University of Texas MD Anderson Cancer Center. "Until now, most people had to rely on emergency medical care to get access to an opioid reversal agent. Having naloxone available for use by caregivers as soon as signs of overdose are observed means an earlier intervention and better chance of survival." 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.

"The FDA approval of EVZIO furthers our mission to make lifesaving products that put patients first," said Spencer Williamson, CEO of kaleo. "We are thankful to the patients and caregivers whose input guided the development process and resulted in an intuitive and important product we're proud to bring to market." 

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