FDA to increase availability of naloxone, an overdose opioid drug

• Naloxone is used primarily in emergency rooms in the United States to treat opioid overdoses that put the patient's life at risk.
• The FDA change paves the way for pharmaceutical companies to sell naloxone without a prescription.

The US Food and Drug Administration (FDA) has announced that it will help pharmaceutical companies increase access to and reduce the cost of naloxone, a drug that is essential for the treatment of opioid overdose.

According to some reports, the change would allow pharmaceutical companies to manufacture an over-the-counter version of naloxone, which has been criticized for being prohibitive and difficult to buy.

According to a press release issued by the US FDA, the treatment and prevention of opioid overdose is a high priority and increasing the availability of the drug for the treatment of overdose in an emergency is a crucial step . One possible way to improve access to the drug was to allow drug manufacturers to develop a readily available version.

FDA Commissioner Scott Gottlieb said that naloxone was an important drug to help reduce the number of deaths from opioid overdose. Mr Gottlieb added that facilitating appropriate treatment in case of opioid overdose is a top priority and that improving the availability of naloxone in emergency situations is a crucial step.

The drug, currently sold as a nasal spray and injection, is widely used in emergency rooms in the United States to address overdose of opioids such as heroin or painkillers such as Fentanyl, Percocet , Vicodin and OxyContin. The drug binds to opioid receptors in the brain and blocks the effects of opioids by reversing the overdose in two to five minutes.

The manufacturer of naloxone, Kaleo Inc., is currently injecting naloxone, Evzio, at approximately $ 4,100 per dose. Kaleo also plans to market a generic version of Evzio that will cost more than $ 178. Meanwhile, a two-component naloxone nasal spray, Narcan is selling for $ 125. Generic naloxone costs about $ 40 per dose.

According to reports, the FDA is also trying to further reduce costs and increase consumer access by designing easy-to-understand labels for over-the-counter versions.