The Food and Drug Administration is clearing the way for drug companies to increase access and lower the cost of a life-saving drug used to treat opioid overdoses.
The FDA said Thursday it is streamlining the labeling for naloxone, a prescription drug that can reverse an opioid overdose if caught early enough. The change will allow drug makers to produce over-the-counter versions of the medication that some have criticized as prohibitively expensive and difficult to buy.
“Naloxone is a critical drug to help reduce opioid overdose deaths,” FDA Commissioner Scott Gottlieb said in a statement. “Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step.”
Naloxone, sold as an injection or nasal spray, is used in emergency rooms across the U.S. to reverse the symptoms of a drug overdose from opioids like heroin or prescription pain medicines like Vicodin, fentanyl, OxyContin and Percocet. It binds itself to opioid receptors in the brain, thereby blocking the drugs and stopping an overdose within two to five minutes.
Naloxone maker Kaleo Inc. has an injection treatment called Evzio that has a list price of USD 4,100. The Company plans to release a generic version of Evzio with a retail price of USD 178 this year. A two-pack of Narcan, a naloxone nasal spray, has a retail price of about USD 125. Generic naloxone costs about USD 40 per dose.
The FDA is trying to lower the cost even more and increase customer access by creating easy-to-understand labels the industry can use as a template for over-the-counter versions that can be sold at pharmacies without a prescription.
Pharmaceutical manufacturers that want to take a drug that is already approved for prescription use and make it available over the counter must first develop a label that consumers can easily understand. Drugmakers must also conduct studies to prove consumers understand how to use products without a doctor’s supervision.
The FDA created two model labels – for a nasal spray and auto-injector. The labels use pictograms to show people how to use the products. The agency also hired an independent research contractor to study more than 700 people who might use naloxone if they use heroin or a friend uses prescription opioids. Companies can use the labels FDA created and tweak them as necessary.
“I personally urge companies to take notice of this pathway that FDA has opened for them and come to the agency with applications as soon as possible,” Gottlieb said.