Estimated read time: 5-6 minutes
SALT LAKE CITY — As the opioid crisis worsened, killing more and more Americans each year, the only drug that could resuscitate someone from a fatal overdose got more expensive.
In 2006, more than 17,500 Americans died from an opioid overdose — in 2017, 47,600 died, according to the National Institutes of Health. During that same time frame, the average price of a 4-milligram naloxone nasal spray went from about $2.60 to over $100. That's a 3,797% increase.
And when COVID-19 hit, the crisis reached a fever pitch with over 100,000 overdose deaths in the first year of the pandemic. The price of naloxone kept rising.
"It was a compounding tragedy," says Michael Hufford. "The fact that pharmaceutical manufacturers had raised the price of the product as the opioid epidemic unfolded, we thought we had to do something about that. And so Harm Reduction Therapeutics was born."
Hufford is the co-founder and CEO of Harm Reduction Therapeutics, a nonprofit pharmaceutical company out of Bethesda, Maryland, that makes an over-the-counter form of naloxone, packaged as a nasal spray.
Called RiVive, it was approved by the FDA in July and will be available in early 2024. It's likely the most affordable naloxone product to date for the public. It's produced by a nonprofit that won't be cashing in on sales; and in an incredible display of poetic justice, the majority of the $30 million Harm Reduction Therapeutics raised to create RiVive came from Purdue Pharma, the opioid manufacturer accused of misleading the public about how addictive OxyContin was.
"This wasn't a for-profit venture. This wasn't about quick, turnaround venture capitalism. This was about getting as many of these out there as possible," said Utah Sen. Jen Plumb, D-Salt Lake City, who founded the group Utah Naloxone, which trains and distributes much of the naloxone available in the state.
Harm Reduction Therapeutics started in 2017 when Hufford attended a conference with the FDA where he says they all but begged pharmaceutical developers to create an over-the-counter naloxone product. Hufford reached out to all the developers he knew to see if they were willing to switch their products to over-the-counter status.
"It was honestly quite disheartening because, without exception, every single manufacturer I reached told me they had no intention," he said.
Naloxone, usually administered through a nasal spray or syringe, was approved by the FDA in 1971. But as demand increased, so did the price.
Data from the National Library of Medicine shows a steady increase for all major applications of naloxone from 2006 to 2017. And researchers from USC documented a 500% increase in naloxone prices from 2014 to 2018, with the average out-of-pocket cost for a single dose increasing from $35 to $250.
Meanwhile, death rates have climbed. The Centers for Disease Control and Prevention estimates that over 1 million Americans have died from overdoses since 1999, and each year claims more people than the last.
This wasn't a for profit venture. This wasn't about quick, turnaround venture capitalism. This was about getting as many of these out there as possible.
–Utah Sen. Jen Plumb, D-Salt Lake City
"This is an area that should not be profit-driven. Naloxone is a reversal medication that essentially stops someone from dying if you get to them in time," Plumb said.
Hufford and his colleagues at Harm Reduction Therapeutics began meeting with the FDA in 2018 — their final application was submitted in 2022, and on July 28 it was approved. By "early 2024" Hufford says it will be available, with priority given to harm reduction groups.
Each pack of RiVive costs about $36 to make and contains two nasal sprayers, Hufford says. That includes a cost offset allowing them to give at least 10% away.
By comparison, most naloxone products range from $100 to $150 for each kit. Plumb says harm reduction groups like Utah Naloxone are eligible for public interest pricing, which initially put the price at around $75 per kit, though it's since gone down to around $50.
She says other auto-injector products in the past have run as high as $4,500.
The hope is that a more affordable form of naloxone will have a ripple effect on existing drug prices. Plumb says it marks the start of a "shifting phase."
"We think it could drive the market down so there will be more cost affordability," she said. "It will make it so states and scrappy, community-based organizations can get more kits for their limited dollars."
Harm Reduction Therapeutics has no shareholders, and has a corporate charter that mandates they give away as much as they can, and sell the product at the lowest price possible.
"Ultimately, our reach is constrained only by the goodwill of our benefactors," Hufford said. The more money they raise, the more naloxone they can give away, or just sell for a lower price.
"That's 180 degrees from your typical pharmaceutical company," he said.
But it comes with a challenge. When Hufford was pitching the idea, he couldn't tell venture capitalists they would make a large return, like other pharmaceutical companies. And meeting the FDA's regulatory requirements takes a lot of capital, with the cost of drug development often nearing $1 billion.
The nonprofit compiled grants and donors to raise about $30 million. Most of that came from Purdue Pharma's bankruptcy settlements. Other funds came through a public health grant administered from Purdue before the bankruptcy.
"If you believe the moral arc of the universe bends towards justice, I can imagine no better use of some of those funds," said Hufford.
