A Game Changer forHigh-Risk Medications

The tide is finally turning on COVID-19, and the world is ready to get back to normal. But normal will mean facing a number of knotty health crises that have been hiding in the pandemic’s shadow—many of which have gotten worse.

The good news is that some of these intractable problems—widespread substance abuse, depression, and chronic pain, for instance—have next-generation, evidence-based treatments. The not-so-good news is that those treatments include highly regulated drugs with a risk of abuse.

How can life-saving drugs be delivered in a way that is equitable, accountable, and safe? Some medical device innovators have drawn a bead on a solution. “Our team wanted to focus on the patient experience as a response to these crises,” says Marcel Botha, an MIT-trained engineer and the driving force behind 10XBeta, a design firm that specializes in intuitive medical technologies.

10XBeta recently unveiled a disruptive idea for delivering high-risk drugs: the Validose device. It’s sleek, palm-size, and can fit in a coat pocket. Botha says it represents a new strategy for treatments that carry risks of misuse.

Validose delivers small, aerosolized doses of scheduled medications. But it can only be activated by the thumbprint of the patient, using the same kind of sensor you might find on a smartphone. Information about the dose is immediately communicated with the physician’s office, and a suite of security measures, built into the design of both the hardware and software, prevent users from taking extra doses or sharing one with a friend. If a person misses a dose, the device can alert the provider to check in.

It's a simple idea that could bring a sea change in the management of some conditions. Botha sees it as a way to transform the delivery technology for a whole spectrum of potentially dangerous medications. “We want Validose to become the gateway between the patient and any medication with the risk of abuse,” he says.

The Validose tool has unlimited potential. But its most promising use will be to help tame two of the most tragic crises in U.S. health care.

The first is the abuse of opioids, which has now killed more Americans than World War II. While heroin and other illegal drugs contribute to the problem, it’s prescription medications—and the way they get misused—that play the primary role. Every day, 46 people in the United States die from overdosing on an opioid that was prescribed by a doctor. For those who use heroin and other illegal opioids, 86% say they were put on that road by a legal opioid prescription for themselves or someone they knew.

The COVID-19 pandemic has only added fuel to the fire. The past year has seen a record high of overdose deaths, up by more than a quarter over the year prior, according to recent data from the Centers for Disease Control and Prevention.

Prescriptions that leave the pharmacy don’t always end up where they’re intended. Diversion is the dark side of the opioid problem, and most people who misuse these medications get them from family members or friends. That’s one of the issues Validose is designed to correct.

There’s a second crisis that Validose can help address. America’s rates of depression and suicide have been climbing for about two decades, a problem that has affected almost every demographic group in the country. During the earliest months of the pandemic, rates of depression almost tripled.

The psychiatric profession is on high alert, and more promising medications are on their way now than in the past several decades. The generic drug ketamine, a tightly controlled substance that has historically been used as a form of anesthesia, shows a transformative promise to head off severe depression.

The nasal spray of ketamine has been found to work for patients with depressive disorders, particularly treatment-resistant depression. It is fast-acting, with clinical trials showing that patients are relieved from suicidal ideation within a few hours, and its sustained effects last up to a week. Most oral antidepressants, in comparison, can take weeks to start working.

These twin crises have helped reduce life expectancy for Americans in a dramatic way. Safely delivering opioids and antidepressants could reverse those trends for good.

The Validose device itself is sleek and white, about the size of a bottle of cough syrup. Under the surface, its security and data-gathering abilities make use of the latest generation of mobile tech.

Medications are dispensed as atomized droplets into the nasal passage, and are absorbed through the nasal mucosal membrane. Each single dose is “locked” through thumbprint security. With that step, Validose may have finally cracked the code for more equitable and harm-free prescriptions: making sure the right dose gets to the right person at the right time.

“We all want to protect the patient and preserve the treatment,” says Botha. “I believe our device can do that.”

The stress of the pandemic has stretched everyone thin. For some, that has meant a tragic turn into substance use or a struggle with mental health. As the pandemic begins to loosen its grip, health care professionals will need new tools to save these collateral victims of COVID-19. The Validose platform will be a powerful addition to that arsenal, and it will help in other crises to come.

In its initial launch, the Validose system will focus on four areas: antidepressants, painkillers, depressants, and abuse treatments. “Under each of those, we are looking at multiple high-risk medications that are already approved for prescription use,” says Botha. “We’re focusing on high-risk, high-value applications for neuroscience, psychiatry, and oncology.”

If just 5% of the U.S. patient population suffering from major depression were treated with Validose, says Botha, then nearly a million people could reduce clinician visits, monitor their own progress, and be protected by layers of security.

Every year, about 235 million prescriptions are written for painkillers, depressants, and substance abuse treatments. These include high-risk medications like fentanyl and buprenorphine. Botha says all of these medications could potentially be used with the Validose system, and Validose is already preparing to test other powerful compounds, including those used to control seizures and treat hyperactivity disorders.

More high-risk medications with lifesaving potential are also coming down the pipeline. Emerging research suggests that substances like psilocybin—the active ingredient in hallucinogenic mushrooms—and cannabinoids—compounds found in marijuana—can help with depression. MDMA has shown promise for treating post-traumatic stress syndrome. No physician wants to risk the recreational misuse of these substances. But Botha says that all of these could be engineered for safer intranasal delivery via Validose.

Miracle medications seldom come without a catch. Validose, which launches late 2021, will be ready as a safe and secure delivery method. Once clinicians determine the right dosages, Validose can deliver benefits to the people who need them most.

For more information on the Validose solution, visit the website.