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Opioid overdose drug Narcan approved for sale without prescription Opioid overdose drug Narcan approved for sale without prescription
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Naloxone, sold under the brand name Narcan, is known for being able to reverse an opioid overdose within minutesNaloxone, sold under the brand name Narcan, is known for being able to reverse an opioid overdose within minutes
A drug that reverses opioid overdoses can now be purchased without a prescription in the US, officials said.A drug that reverses opioid overdoses can now be purchased without a prescription in the US, officials said.
The Food and Drug Administration's approval means naloxone can be sold as a single-dose nasal spray in convenience and grocery stores. Approval by the Food and Drug Administration (FDA) means naloxone can be sold as a single-dose nasal spray in convenience and grocery stores.
Until now, Narcon - the nasal spray version of naloxone - was only available through a pharmacist or at local health centres.Until now, Narcon - the nasal spray version of naloxone - was only available through a pharmacist or at local health centres.
FDA's commissioner Robert Cliff called the move "a dire public health need". FDA commissioner Robert Cliff called the move "a dire public health need".
The move to widen the availability of Narcan is the latest effort to tackle an alarmingly high drug fatality rate in the country. Widening the availability of Narcan is the latest effort to tackle an alarmingly high drug fatality rate in the US.
"Today's approval of (over-the-counter) naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country," Mr Califf said in a statement on Wednesday. "Today's approval of (over-the-counter) naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available, and help reduce opioid overdose deaths throughout the country," Mr Cliff said in a statement on Wednesday.
More than 100,000 Americans died from drug overdoses last year, according to FDA. The vast majority were adults, though numbers show that teen overdose rates are rapidly rising. More than 100,000 Americans died from drug overdoses last year, according to the FDA. The vast majority were adults, though numbers show that teen overdose rates are rapidly rising.
US teens fastest growing group to die from fentanyl overdoseUS teens fastest growing group to die from fentanyl overdose
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. Narcan has been available at pharmacies since it gained FDA approval in 2015, but only with a prescription. It has also been distributed through local health departments, community centres and needle exchange programmes in some states.
It reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.It reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.
It can restore normal breathing to a person experiencing an opioid overdose in two to three minutes.It can restore normal breathing to a person experiencing an opioid overdose in two to three minutes.
In cases involving more powerful opioids like fentanyl, more than one dose of naloxone is often required to reverse an overdose.In cases involving more powerful opioids like fentanyl, more than one dose of naloxone is often required to reverse an overdose.
Since its approval in 2015, Narcan has been available at pharmacies but only with a prescription. It has also been distributed through local health departments, community centres and needle exchange programs in some states.
Wednesday's action paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.Wednesday's action paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
Currently, it applies only to a four milligram dosage of the drug. Other doses of naloxone will remain available through a prescription only, the FDA said.Currently, it applies only to a four milligram dosage of the drug. Other doses of naloxone will remain available through a prescription only, the FDA said.
The FDA and the pharmaceutical company behind Narcan, Emergent BioSolutions, said consumers will likely see the drug available over-the-counter in a few months. The FDA and the pharmaceutical company behind Narcan, Emergent BioSolutions, said consumers will likely see the drug available over the counter in a few months.
Emergent BioSolutions has declined to disclose the price it plans for an over-the-counter version of Narcan. Emergent BioSolutions has declined to disclose the price it plans for that version of Narcan.
Related TopicsRelated Topics
OpioidsOpioids
Prescription drugsPrescription drugs
Drug useDrug use
United StatesUnited States