A Pittsburgh nonprofit is creating over-the-counter naloxone with help from OxyContin maker Purdue Pharma

“As the opioid crisis unfolded, the cost of naloxone substantially increased,” the CEO of Harm Reduction Therapeutics said.

Injectable naloxone, the so-called overdose antidote, is pictured.

Injectable naloxone, the so-called overdose antidote, is pictured.

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The maker of OxyContin is giving more than $3 million to a Pittsburgh-based nonprofit to expedite the development of an over-the-counter form of the naloxone nasal spray, the so-called overdose antidote.

The $3.42 million grant from Stamford, Conn.’s Purdue Pharma to Harm Reduction Therapeutics in Pittsburgh was announced Wednesday as part of the pharmaceutical giant’s push to combat side effects of the opioid epidemic — the seeds of which were planted by Purdue itself.

“Purdue is committed to advancing patient care and public safety,” Craig Landau, president and CEO of Purdue Pharma, said in a statement. “While naloxone accessibility cannot be seen as a single solution, it must be part of our collective actions.”

In a phone call with The Incline, Harm Reduction Therapeutics’ CEO Michael Hufford called the Purdue grant the first piece in a puzzle that, once complete, will make naloxone more accessible and more affordable. Hufford said the Purdue grant will help Harm Reduction Therapeutics get its New Drug Application submitted to the U.S. Food and Drug Administration.

“The FDA approved naloxone in 1971, and it’s been off-patent since ‘85,” said Hufford, who obtained his Ph.D. from Pitt. “But as the opioid crisis unfolded, the cost of naloxone substantially increased. Meanwhile, the cost of heroin has continued to go down, and the purity of heroin has continued to go up.”

Hufford added, “[Naloxone] itself costs less than a dollar to save a life, yet the retail price for intranasal forms of naloxone is over $100 and for intramuscular forms it’s over $4,500. And I saw that as unconscionable.”

Hufford said he also saw an opportunity to help naloxone go over the counter while addressing cost and access simultaneously. Hufford said you address access by taking the drug over the counter and cost by selling it as a nonprofit “at the lowest possible price.”

Beyond the Purdue grant and the FDA approval process, Hufford said money will need to be raised by Harm Reduction Therapeutics for outreach, manufacturing and awareness campaigns. That manufacturing campaign will be relatively limited, at least by big pharma standards, and dependent on the success of those fundraising efforts.

“Our goal is to have an initial run in excess of a million units,” Hufford said. “But the total need for naloxone is in the many millions of units a year, although it’s hard to get good numbers on that.”

He continued: “There are glass vials of naloxone that sit in every ER in the U.S. and on pharmacy shelves in every hospital. We’re not going after that market. Our market is two-fold: 1. To get it in the hands of consumers like any other over-the-counter product, and 2. Trying to address the needs of first responders and municipalities who have been breaking the bank trying to afford naloxone.”

In Middletown, Ohio, for example, a member of city council last year proposed withholding naloxone from repeat overdose victims citing the cost and the strain on emergency services, according to the Washington Post. In Pennsylvania, Gov. Tom Wolf announced $5 million included in the 2017-18 budget to provide naloxone to first responders. Wolf and Physician General Dr. Rachel Levine also issued a standing order in 2015 making naloxone available over the counter at pharmacies here, but that order didn’t directly address the price point.

How much Harm Reduction Therapeutics would sell its over-the-counter naloxone spray for is yet to be determined and dependent on the amount of money it raises from grantors like Purdue, but Hufford said it will be a “fraction of the price of current products.”

Hufford said Harm Reduction Therapeutics is in talks with “dozens of philanthropies and high network folks” in its search for funders, adding of Purdue’s $3.42 million grant, “We would love to see this be the first of multiple contributions.”

He also addressed the elephant in the room, so to speak: Was he comfortable taking money from Purdue?

The corporation fueled the opioid crisis by lying to patients and doctors about the risks of addictive products like OxyContin and by targeting vulnerable populations, all while raking in huge profits. It’s paid millions in settlements, and in 2007 agreed to pay a $600 million penalty for misbranding OxyContin and misrepresenting associated risks. In February, Purdue said it would stop marketing OxyContin to doctors, CNN reported at the time.

Purdue is one of a number of big pharmaceutical companies being sued for its hand in creating the opioid crisis. A number of states have sued Purdue, in particular, accusing the company of deceptive marketing of its prescription painkillers. There have also been lawsuits filed by local governments and municipalities, including Pittsburgh and Allegheny County. According to the Tampa Bay Times, the number of lawsuits against the industry being overseen by a federal judge topped 1,000.

But Hufford said he welcomes Purdue’s investment in life-saving treatments like naloxone now.

“I would answer this question with a favorite quote of mine from Mary Lasker who formed the American Cancer Society and Planned Parenthood and who was a very famous philanthropist. She said, ‘Money is frozen energy, and you unfreeze it when you pay people to work.’ And that’s how I see investment capital. It is frozen energy, and what we need at the end of the day isn’t good wishes, what we need is capital, and so we’re pleased and grateful to Purdue for this. […] I think this is the direction things should be going.”

The Incline posed a similar question to Purdue: Was it too little too late for the company to now become concerned with the impacts and consequences of the opioid epidemic, and was the Harm Reduction Therapeutics grant all just a PR move?

In an email, Purdue spokesperson Robert Josephson wrote, “In response to critics, we share their concerns about the opioid crisis and are committed to working collaboratively with all stakeholders to help stem the tide of this public health crisis.”

He added, “It is a bit hypocritical to demand that the pharmaceutical industry step up and help address the opioid crisis and then criticize such important public health efforts. […] We have long supported access to naloxone and have funded such initiatives in the past. Since 2014, we have partnered with the National Sheriffs’ Association on training and access to naloxone. This program is credited with saving approximately 275 lives to date, and Purdue has provided $850k.”

More than 72,000 Americans died from drug overdoses in 2017, including illicit drugs and prescription opioids, according to the CDC. That’s a two-fold increase over the last decade.

In Allegheny County, there were 737 drug overdose deaths recorded in 2017 alone, according to data provided by the county. It was the highest number here in a 10-year-period that saw 3,800 fatal overdoses in total.