FDA opens door to ease access to opioid overdose antidote

The Food and Drug Administration is pushing drugmakers to seek over-the-counter approval of naloxone, the antidote to opioid overdoses.

In a notice posted online Tuesday, the agency said it “strongly encourages” naloxone manufacturers to contact the FDA “as soon as possible” to initiate a discussion about a potential switch from prescription to over-the-counter.

It’s a move, experts say, that would remove barriers to access to life-saving drugs, which can reverse the effects of an opioid overdose when given on time. The FDA said two forms of the drug — a nasal spray and an auto-injector — could potentially be safe and effective for over-the-counter use.

Naloxone is only available by prescription, although many states have found alternatives to make it easier to get the drug. Through what are called standing orders, for example, people can request naloxone from a pharmacist.

By making drugs available without a prescription, it eliminates the stigma, said Dr. Scott Hadland, addiction specialist at Mass General for Children in Boston. People could buy it online or in-store through self-checkout.

There has been great pressure from advocacy groups in recent years to make the drug more readily available, said Dr. Michael Barnett, assistant professor of health policy and management at Harvard TH Chan School. of Public Health.

More than 107,600 Americans died of drug overdoses last year, according to the Centers for Disease Control and Prevention, the highest annual death toll on record. The majority involved fentanyl, a powerful synthetic opioid. Nearly 20,000 overdose deaths between 1999 and 2020 were prevented by self-administering naloxone, according to the FDA.

The FDA notice provides a pathway to product approval and requests more information from drugmakers about how the drug would be sold. Over-the-counter naloxone is still expected to go through the FDA for review and approval, Barnett said, but could start rolling out to pharmacy shelves as early as next year.

The agency specifically mentioned two products that could be potential candidates for over-the-counter use: up to 4 milligrams of Narcan, a nasal spray from Emergent BioSolutions, and up to 2 milligrams of Evizo, an auto- Kaleo single-use injection. These products are easy to use, the agency wrote, because they don’t require additional supplies or medical training.

Naloxone products that come in higher doses and other forms of the drug for which more safety data is still needed, such as those that come in glass vials and ampoules, should still be prescribed by a physician, the FDA said.

Despite efforts by many states to make naloxone more widely available, obstacles remain.

Some patients might be reluctant to ask a pharmacist for the drug, due to the stigma surrounding addiction. According to the Association of American Medical Colleges, more than 21 million people in the United States suffer from addiction, and only 11% of them receive the treatment they need.

Additionally, some pharmacists may be unaware that there is a standing prescription in their state and refuse to prescribe the drug altogether.

Hadland said he’s also seen patients denied life insurance coverage after the drug appeared on their health insurance bill and the life insurance provider believed they were at risk. an overdose.

Making the drug available without a prescription also means that people would not have to rely on the protection of Good Samaritan legislation when administering the drug, said Dr Anna Lembke, medical director of addiction medicine at Stanford. These laws provide limited legal protection to people who help an injured or sick person.

“If it were to be made over-the-counter, all of that would be moot and the average person could buy it without a prescription and without needing legal protection to administer it,” she said.

The FDA noted that over-the-counter naloxone will not divert supplies from community naloxone programs and hospitals.

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