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A hand-held autoinjector that delivers a single dose of naloxone to be used in cases of suspected or known opioid overdoses has been approved by the Food and Drug Administration.
The treatment "is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting," said Dr. Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. "Making this product available could save lives by facilitating earlier use of the drug in emergency situations," he added in an FDA statement announcing the approval April 3.
The product’s application was granted priority review status by the agency and reviewed in only 15 weeks, FDA Commissioner Margaret A. Hamburg said in a separate statement.
The autoinjector will be marketed by kaléo, Inc., under the trade name Evzio. It can be administered subcutaneously or intramuscularly, and is intended to be administered by family members or caregivers in cases of suspected overdoses, the statement said. As with automated defibrillators, verbal instructions and visual clues regarding how to use the device are provided when activated. A trainer device is included with the product for people to become familiar with how to use the device.
The FDA statement notes that deaths due to drug overdoses are currently the leading cause of fatal injuries in the United States, and that in 2013, the Centers for Disease Control and Prevention reported that drug overdose deaths had increased steadily over 10 years.
While naloxone is the standard treatment for overdoses, it has been available for administration only with syringes by health care professionals.
The product is expected to be available though major pharmacies this summer, according to a kaléo statement announcing the approval.
A hand-held autoinjector that delivers a single dose of naloxone to be used in cases of suspected or known opioid overdoses has been approved by the Food and Drug Administration.
The treatment "is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting," said Dr. Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. "Making this product available could save lives by facilitating earlier use of the drug in emergency situations," he added in an FDA statement announcing the approval April 3.
The product’s application was granted priority review status by the agency and reviewed in only 15 weeks, FDA Commissioner Margaret A. Hamburg said in a separate statement.
The autoinjector will be marketed by kaléo, Inc., under the trade name Evzio. It can be administered subcutaneously or intramuscularly, and is intended to be administered by family members or caregivers in cases of suspected overdoses, the statement said. As with automated defibrillators, verbal instructions and visual clues regarding how to use the device are provided when activated. A trainer device is included with the product for people to become familiar with how to use the device.
The FDA statement notes that deaths due to drug overdoses are currently the leading cause of fatal injuries in the United States, and that in 2013, the Centers for Disease Control and Prevention reported that drug overdose deaths had increased steadily over 10 years.
While naloxone is the standard treatment for overdoses, it has been available for administration only with syringes by health care professionals.
The product is expected to be available though major pharmacies this summer, according to a kaléo statement announcing the approval.
A hand-held autoinjector that delivers a single dose of naloxone to be used in cases of suspected or known opioid overdoses has been approved by the Food and Drug Administration.
The treatment "is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting," said Dr. Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. "Making this product available could save lives by facilitating earlier use of the drug in emergency situations," he added in an FDA statement announcing the approval April 3.
The product’s application was granted priority review status by the agency and reviewed in only 15 weeks, FDA Commissioner Margaret A. Hamburg said in a separate statement.
The autoinjector will be marketed by kaléo, Inc., under the trade name Evzio. It can be administered subcutaneously or intramuscularly, and is intended to be administered by family members or caregivers in cases of suspected overdoses, the statement said. As with automated defibrillators, verbal instructions and visual clues regarding how to use the device are provided when activated. A trainer device is included with the product for people to become familiar with how to use the device.
The FDA statement notes that deaths due to drug overdoses are currently the leading cause of fatal injuries in the United States, and that in 2013, the Centers for Disease Control and Prevention reported that drug overdose deaths had increased steadily over 10 years.
While naloxone is the standard treatment for overdoses, it has been available for administration only with syringes by health care professionals.
The product is expected to be available though major pharmacies this summer, according to a kaléo statement announcing the approval.
