The US drug agency approves the over-the-counter sale of an antidote for opioid overdoses

A community center worker demonstrates how to use Narcan to reverse an overdose, last August in New York.Spencer Platt (Getty Images)

The US Food and Drug Administration (FDA in its English acronym; federal agency) has approved this Wednesday the over-the-counter sale of naloxone to reverse opioid overdose, an epidemic that claims more than 100,000 lives a year.

The approval is limited to Narcan, a trademark of naloxone from the Emergent BioSolutions laboratory.

The FDA's decision means that Narcan will be available in grocery and convenience stores, at a price yet to be determined.

Many addicts already had access to naloxone in community groups and in the very few drug rooms that exist in the country.

Social workers, NGOs and paramedics who live daily with the epidemic of overdoses - many of them due to fentanyl, an opioid between 50 and 100 times more powerful than morphine - have been demanding free access to this medicine that can save lives for some time;

in fact, police and emergency services workers often carry it with them.

In its FDA-approved trademark, it's a nasal spray that can reverse opioid overdoses, including street drugs like heroin and fentanyl and prescription drugs like oxycodone, prescribed as pain relievers for chronic pain.

Expanding access to naloxone is seen as a key strategy to control the nation's overdose crisis, the worst public health crisis in the US since AIDS in the 1980s and 1990s.

Most overdoses are caused by powerful synthetic versions like fentanyl, which can require multiple doses of naloxone to reverse.

Those who advocate liberalizing its use argue that expanding access to the drug to those close to drug addicts, including themselves and their families, is a lifeline in the face of preventable deaths.

Even before the FDA approval, pharmacies could sell naloxone without a prescription because authorities in every state have allowed it.

But not all pharmacies sell it.

And buyers have to pay for the drug, either with an insurance copay or full retail price.

The cost varies, but two doses of Narcan usually cost about $50.

Emergent hasn't announced its pricing and it's not yet clear if insurance companies will continue to cover it as a prescription drug once it becomes available without a prescription.

deadly new drugs

Narcan will be available in stores and supermarkets later this summer, according to Emergent BioSolution.

Other brand names of naloxone, including injectable vials, are not yet available over the counter, but could soon follow Narcan's lead.

The NGO Harm Reduction Therapeutics, which is funded by the pharmaceutical company Purdue Pharma, the main cause of the opioid epidemic, has applied to the FDA to distribute its version of naloxone in aerosol without a prescription.

With the marketing of its flagship drug, Oxycontin (oxycodone), prescribed to relieve pain in terminally and chronically ill patients, Purdue Pharma fueled the addiction crisis, as proven by successive legal proceedings undertaken by survivors, relatives and local administrations.

Although oxycodone maintains its leading role, along with fentanyl, in the opioid epidemic, the drug market's ability to adapt and reinvent itself continues to wreak havoc, with continuous mutations in its supply.

Just three days ago, New York Democratic Senator Chuck Schumer asked the US Drug Enforcement Agency (DEA) to deploy a special team to stop the proliferation and consumption of a deadly new form, called Xylazine, which often mixed with fentanyl and heroin.

According to Schumer, it is related to dozens of overdose deaths throughout upstate New York, and is now landing in the Big Apple and Long Island.

In addition, it is resistant to Narcan, the senator has emphasized.

Xylazine is a drug for veterinary use,