In Mental Health Therapy, Cautious Steps Toward the Pharmacodigital

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has been through about half a dozen randomized controlled trials across groups of people struggling with various addictions. Pear is licensing the program—known by its acronym TES—from a small business affiliated with Lisa Marsch, director of the Center for Technology and Behavioral Health at Dartmouth College. (Dartmouth has no financial connections to TES.)

“The academics have done the heavy lifting,” says McCann.

“Pear’s model is to push [the addiction therapy program] in an entirely new direction we hadn’t planned to pursue,” says Marsch. “They’re packaging this empirically supported behavioral health tool with medication.”

Marsch: "New directions we hadn't planned."

Marsch: “A new direction we hadn’t planned.”

Some anti-addiction medicines work well, too. Buprenorphine, for abuse of opioids such as heroin or prescription pills, “is very safe and effective,” says Marsch. “It stabilizes the brain chemistry and controls cravings, but using it alone, you don’t learn anything.”

The idea for all of Pear’s products is to put an access code right on the pill bottle or package. A patient would use the code to get software or an app, and the digital therapy would complement the chemical treatment. The digital part of the equation would also allow doctors to follow patient progress and know more quickly when adjustments are needed.

Once Pear proves it can make that model work, it wants to work with pharma companies to pair their new drugs (yes, the pun is intended) with Pear’s customized digital therapies—with the drug companies paying the clinical trial costs.

What will these multimodal therapies look like, and how will they work? For anxiety and panic attacks, the pharmaceutical standard is benzodiazepine. But when an attack comes on, popping a pill doesn’t work right away. In the 30 minutes of waiting, or more, McCann imagines the patient using digital content on a smart phone as “a bridge to the [drug’s] onset,” with deep breathing and meditation exercises that are clinically validated. “These are coping skills derived from cognitive behavioral therapy,” he says.

The app could have a virtual coach—an avatar who guides the patient—and it could measure the patient’s breathing (from blowing into the microphone) and heart rate (through a plug-in monitor or by having the camera measure pulse through a finger). Many of these components, as well as the feedback loops that let doctors track patient progress, will be additions Pear builds itself or licenses from software developers.

A person struggling with addiction might consult his or her phone app in a moment of crisis—out at night with friends, say, and faced with a tempting offer of drugs or alcohol. “It needs to be sufficiently engaging so that consumers want to come back and use the software,” McCann says. (Here’s one small piece of the academic version of the addiction intervention program.)

Just as Pear is building the digital apps upon a body of work, it will move through the regulatory process step by step. The strategy is to first ask FDA for approval for its software under what’s known as the 510(k) pathway, which governs medical devices. (Note that a 510(k) clearance doesn’t require clinical evidence. It’s also cheap to attain, probably less than $1 million, according to Pear’s lead investor Andy Schwab, a managing partner at 5am Ventures.)

Eventually, however, Pear expects its “eFormulations” will be greater than the sum of their parts. Past a certain point, they’ll need permission to make medical claims about the benefits of the combination, through what’s known as a 505(b)(2) approval. That means spending some money on clinical trials, although not necessarily what a company with a brand new drug would spend, because Pear, using generics, can lean partially on studies by previous researchers. (McCann says he’ll be out raising a new round of financing this year.)

The PTSD product will be based on a virtual reality immersion called Bravemind, developed at the University of Southern California’s Institute for Creative Technologies. “Without any combat experience, you might say it’s a low-rent version of Call of Duty,” says Albert “Skip” Rizzo, a psychologist and the institute’s associate director for medical virtual reality. “Someone who was [in Iraq or Afghanistan] but doesn’t have PTSD would probably say, ‘Oh, this is interesting.’ Someone with PTSD would have a more … Next Page »

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One response to “In Mental Health Therapy, Cautious Steps Toward the Pharmacodigital”

  1. rob says:

    Whenever I see the phrase, as on page 2 of the article….with drug companies paying the cost of clinical trials….I immediately doubt the veracity of the study outcomes. There is inherently a conflict of interest.

    Having said that, I do think the idea of digital therapy, or virtual reality therapy sounds fascinating. Any treatment that helps unburden a person dealing with mental illness is worth a try. Thanks for the article.