WASHINGTON (CIRCA) - Opioid overdose antidote naloxone can be picked up at most pharmacies across the United States, but it is not as simple as walking in the store and grabbing it off the shelf.
Nonprofit Harm Reduction Therapeutics wants to try and change that by officially bringing the lifesaving drug over the counter.
"We want it to be as easily available as Tylenol," said Harm Reduction Therapeutics co-founder and CEO Michael Hufford.
Naloxone, commonly referred to as brand-name Narcan, can reverse the effects of an opioid overdose and is technically classified as a prescription only drug by the Food and Drug Administration.
"The FDA only has two categories, prescription only or OTC (over-the-counter), and we have sort of that gray area in the middle," said Kelly Orr, a clinical professor and director of the Doctor of Pharmacy Program at the University of Rhode Island.
And in at least 48 states, naloxone lives in that gray area because of state standing orders, which allow people to pick up the medication from a pharmacist without an individual prescription from a doctor.
But Hufford said these standing orders still fail to meet the need.
“One, if you actually go to buy naloxone yourself, what you find is that many pharmacists are not aware of the standing orders. They may or may not have it in stock and depending on your insurance, you may pay full retail price,” he said.
So, Harm Reduction Therapeutics was founded with the goal of making an over-the-counter version of naloxone to increase access and decrease the price.
“While it’s only one very small part of combating the opioid epidemic, we really want naloxone to be every bit as available as, let’s say, heroin is today," said Hufford.
To officially switch the drug’s classification, Hufford and his non-profit will need to prove to the FDA that the drug is safe to use without any medical supervision.
The agency has been willing to help in the process by developing the required label with the instructions for safe use.
“The FDA, I think, has lowered the bar as much as they reasonably can, and it’s really up to the pharmaceutical industry now to step up to reduce the price of these products,” said Hufford.
But whether bringing the livesaving drug over-the-counter will actually reduce the price is still up for debate.
“While it’s only one very small part of combating the opioid epidemic, we really want naloxone to be every bit as available as, let’s say, heroin is today."
"Unfortunately, I don’t think the FDA is going to take in account cost when they’re doing their review. That’s not their job to look at what the cost will be," said Orr.
And if the cost of over-the-counter naloxone is too high, that could be a barrier to those seeking access, said clinical professor at the University of Rhode Island’s College of Pharmacy Jeff Bratberg.
"If it’s too costly, we are going to create or sustain the great divide that we see in health care between people with money and insurance and people without money and insurance," Bratberg said.
Hufford said he does not know exactly what the cost will be, but Harm Reduction Therapeutics' nonprofit status will help make it a fraction of what the current cost is.
"For us, removing profit from the equation lets you just focus on getting the product out as cheaply as possible,” said Hufford.
Either way, Bratberg said creating multiple channels to the lifesaving drug is a positive.
And if it does go over the counter, Orr said, people should not forget about the pharmacists.
"We have special training in nonprescription drugs as well, so we are there to assist with any prescription or nonprescription question. So, even if this does go OTC, please think of the pharmacist as (a) resource," said Orr.
Hufford said they are currently working with the FDA and the approval process could take up to two years.
Harm Reduction Therapeutics received a grant for $3.4 million to help with the process from Purdue Pharmaceuticals.