US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals

FDA underscored its interest in proposals for allowing OTC access to naloxone for treating opioid overdose by taking the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies.

Harm Reduction Therapeutics Inc. already is working on an Rx-to-OTC switch for naloxone and intends to launch a product in the US around mid-2020. Michael Hufford, CEO of the Pittsburgh-based non-profit, says FDA is giving the industry a valuable assist with the model DFLs and the study results.

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Michael Hufford
What’s Taking So Long for Naloxone to Be Made Available Over the Counter?

Naloxone can reverse an opioid overdose within minutes. Prompt access would prevent many of the 130 opioid-related deaths that occur in the United States every day. A recent CDC analysis of 11,884 opioid-involved overdose deaths across 11 states found that bystanders were present in about 40 percent of cases, but naloxone “was rarely administered by a layperson.” Naloxone is also cheap to make.

So why is it taking so long—and costing so many thousands of lives—to make naloxone accessible to everyone as an over-the-counter (rather than prescribed) medication?

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Michael Hufford
The costs of heroin and naloxone: a tragic snapshot of the opioid crisis

The pricing and availability of drugs — legal and illegal — illuminate how markets chase profits and reward innovation. A comparison of heroin (and other illicit opioids) with naloxone, the lifesaving antidote for opioid overdoses, offers a devastating peek into the overdose epidemic that is ravaging the United States.

Given the ongoing devastation of the opioid crisis, you might expect that naloxone would be widely available at a low price. Not so. A decade ago, a lifesaving dose of naloxone cost $1. Today, that same dose costs $150 for the nasal spray, a 150-fold increase. A naloxone auto-injector, approved in 2016, costs $4,500.

Pharmaceutical innovation hasn’t driven up these prices. Opportunity has.

Market forces are working from opposite directions to boost the death count from opioids. In the midst of this crisis, lethally potent street drugs are increasingly affordable and available, while their lifesaving antidote, naloxone, is increasingly expensive and difficult to obtain.

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Michael Hufford
HRT receives a $3.42M grant from Purdue Pharma

Harm Reduction Therapeutics’ work to develop and sell a low cost, over-the-counter naloxone nasal spray is now rapidly moving forward thanks to a $3.42M grant from Purdue Pharma L.P. We are a nonprofit pharmaceutical company working to break down price and access barriers by bringing naloxone over-the-counter (OTC) at the lowest possible price. These funds are an important step towards our goal of making low cost OTC naloxone as widely available as possible

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Michael Hufford
SOS: Stopping Opioid Slaughter

The price of naloxone has been rising precipitously in the past few years. But it could still be manufactured very cheaply, according to biotech entrepreneur Michael Hufford. This is critically important because a person who has overdosed on a powerful synthetic opioid like fentanyl may need multiple doses to be revived. Sometimes emergency personnel revive someone in the morning only to be called back to do it again that night. Some counties have been running out of their entire month’s supply of naloxone in a single weekend.

So Hufford founded a new nonprofit drug company called Harm Reduction Therapeutics, with a mission to prevent fatal opioid overdoses by making low-price naloxone widely available. “I just kept thinking, someone has to raise capital, get regulatory approvals, find suppliers, line up retailers. I became convinced that the best way to do that in this case is as a nonprofit.” If the model succeeds, Hufford sees a role for nonprofit pharmaceuticals in developing other therapies for unmet needs that serve public health.

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Michael Hufford
Nonprofit Pharma Targets Making Naloxone Available OTC, Trimming Price

Nonprofit Harm Reduction Therapeutics targets an OTC switch of naloxone, an opioid antagonist used to reverse an opioid overdose. It aims to make the product available at low cost in 110,000 retail locations nationwide.

“I’ve been doing drug development for 20 years and fundamentally, people’s lives are being lost because of a combination of inadequate access and excessive cost” for naloxone, said Hufford, who has co-founded multiple pharma, medical device and mobile health companies, led pharmaceutical development teams through FDA approvals and assisted in Rx-to-OTC switches.

Conversely, as naloxone's cost has increased and its availability remains largely unchanged, the cost of heroin has dropped amid growing availability. “What’s happened to heroin versus naloxone, they are tragic mirror images of each other,” he said.

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Michael Hufford
If You Can’t Afford $4,500 for a Dose of Medicine, You Don’t Get to Live

Pharmaceutical price gouging has created a situation where access to life-saving medicines is limited by profit margins. As government agencies are already struggling with costs, the burden gets shifted to the private consumer. In that market, the message is clear: If you can’t afford $4,500 for a dose of medicine, you don’t get to live. 

Harm Reduction Therapeutics is a nonprofit pharmaceutical company that is working to maximize naloxone’s over-the-counter availability while minimizing the price and financial burdens to consumers, first responders, and state and local governments. Co-founder and CEO Michael Hufford noted that “philanthropic foundations backing this new nonprofit pharmaceutical model will help with an urgently needed response to the opioid crisis, while realizing a tremendous return on their investment, measured not in dollars, but in lives saved.”

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Michael Hufford
Broken Bad: Exploiters and their Perverse Profits from the Opioid Epidemic

Naloxone — the antidote for opioid overdoses — has become a perfect and tragic example of such exploitation. First approved by the FDA in 1971, naloxone has been shown to be successful in reversing overdoses in 98.8% of cases.[5] Drug overdoses now kill more Americans than traffic accidents or gun violence. In 2016, roughly 64,000 people in the U.S. died from drug overdoses.[6] Before the opioid epidemic blossomed into public consciousness, one milliliter of generic naloxone cost about $1. But as demand has increased, so have prices. Today, even though naloxone is a generic drug that has been widely used for decades, it is expensive, costing between $110–$4,000 as a nasal spray or autoinjector for use by nonmedical personnel. What’s more, its price has gone up as the need has risen — 95%-500% price increases over the past few years.[7] Indeed, the high cost of naloxone has led some city councils to propose canceling emergency responses to overdose cases, to “put fear” into addicts.[8]

Addressing market inefficiencies is a matter of life and death, and is urgently needed. One unique approach that holds great promise is public health-oriented direct competitors to Exploiters is a nonprofit pharmaceutical model, where nonprofit foundation funding is combined with drug development expertise to produce and sell products without a profit motive, could add new products and a healthy new competitive tension to the pricing and access of life-saving medicines. It could also help to deflate the ballooning prices charged by Exploiters for these life-saving medicines.

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Michael HuffordComment